- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922970
Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT. (STEPS)
Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.
In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.
Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.
The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.
If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- University Hospital Copenhagen - Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
- ≥ 18 years old
Exclusion Criteria:
- Illness or physical handicap making it impossible to participate in the training intervention
- Pregnancy
- Not Danish or English speaking
- Anemia
- Already performing regular structured physical training
- Strict vegan or vegetarian diet
- Illness or ongoing treatment that hinders study examinations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Strength training
In this arm participants will go through the "Strength training intervention".
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The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks).
The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength.
The leg exercises are leg press, knee extension and leg curl.
In addition, participants will perform two upper body exercises.
Physical assessment will take place immediately and monthly until 4 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in cross sectional area of m. quadricpes femoris.
Time Frame: 1 week pre intervention
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Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
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1 week pre intervention
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Changes in cross sectional area of m. quadricpes femoris.
Time Frame: 1 week post intervention
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Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
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1 week post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in components of the Metabolic Syndrome: Waist circumference
Time Frame: 1 week pre intervention
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Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week pre intervention
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Changes in components of the Metabolic Syndrome: Waist circumference
Time Frame: 1 week post intervention
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Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week post intervention
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Changes in components of the Metabolic Syndrome: Triglycerides
Time Frame: 1 week pre intervention
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Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week pre intervention
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Changes in components of the Metabolic Syndrome: Triglycerides
Time Frame: 1 week post intervention
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Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week post intervention
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Changes in components of the Metabolic Syndrome: HDL-cholesterol
Time Frame: 1 week pre intervention
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Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week pre intervention
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Changes in components of the Metabolic Syndrome: HDL-cholesterol
Time Frame: 1 week post intervention
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Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week post intervention
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Changes in components of the Metabolic Syndrome: Fasting glucose
Time Frame: 1 week pre intervention
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Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week pre intervention
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Changes in components of the Metabolic Syndrome: Fasting glucose
Time Frame: 1 week post intervention
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Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome.
We will report changes in the number of components fulfilled.
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1 week post intervention
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Changes in components of the Metabolic Syndrome: Blood pressure
Time Frame: 1 week pre intervention
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Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
1 week pre intervention
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Changes in components of the Metabolic Syndrome: Blood pressure
Time Frame: 1 week post intervention
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Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled. |
1 week post intervention
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Hip circumference
Time Frame: 1 week pre intervention
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Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.
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1 week pre intervention
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Hip circumference
Time Frame: 1 week post intervention
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Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.
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1 week post intervention
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Urine sample - microalbuminurea
Time Frame: 1 week pre intervention
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A urine sample for analyses of microalbuminurea in mg/L.
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1 week pre intervention
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Urine sample - microalbuminurea
Time Frame: 1 week post intervention
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A urine sample for analyses of microalbuminurea in mg/L.
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1 week post intervention
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Muscle strength of quadriceps femoris
Time Frame: 1 week pre intervention
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Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer
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1 week pre intervention
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Muscle strength of quadriceps femoris
Time Frame: 1 week post intervention
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Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer
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1 week post intervention
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Handgrip strength
Time Frame: 1 week pre intervention
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Handgrip strength measured with handheld Dynamometer
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1 week pre intervention
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Handgrip strength
Time Frame: 1 week post intervention
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Handgrip strength measured with handheld Dynamometer
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1 week post intervention
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Muscle performance: Timed-up-and-go
Time Frame: 1 week pre intervention
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Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees.
From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome.
The lowest score of three consecutive tries will be used in the analysis.
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1 week pre intervention
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Muscle performance: Timed-up-and-go
Time Frame: 1 week post intervention
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Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees.
From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome.
The lowest score of three consecutive tries will be used in the analysis.
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1 week post intervention
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Muscle performance: Sit-to-stand 30 sec.
Time Frame: 1 week pre intervention
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Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle.
The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec.
The arms should be crossed in front of the body or hanging by the side.
Number of repititions is the outcome.
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1 week pre intervention
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Muscle performance: Sit-to-stand 30 sec.
Time Frame: 1 week post intervention
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Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle.
The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec.
The arms should be crossed in front of the body or hanging by the side.
Number of repititions is the outcome.
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1 week post intervention
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Muscle performance: Sit-to-stand 60 sec.
Time Frame: 1 week pre intervention
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Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle.
The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec.
The arms should be crossed in front of the body or hanging by the side.
Number of repititions is the outcome.
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1 week pre intervention
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Muscle performance: Sit-to-stand 60 sec.
Time Frame: 1 week post intervention
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Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle.
The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec.
The arms should be crossed in front of the body or hanging by the side.
Number of repititions is the outcome.
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1 week post intervention
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Cardiorespiratory fitness: 6 minute walk test
Time Frame: 1 week pre intervention
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6 min.
walk test: The participant walks as far as possible on a 15 m lane in 6 min.
Distance in meters is the outcome.
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1 week pre intervention
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Cardiorespiratory fitness: 6 minute walk test
Time Frame: 1 week post intervention
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6 min.
walk test: The participant walks as far as possible on a 15 m lane in 6 min.
Distance in meters is the outcome.
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1 week post intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Histology of thigh muscle
Time Frame: 1 week pre intervention
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Muscle biopsy sampled from the vastus lateralis muscle, with a Bergstroem needle with manual suction.
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1 week pre intervention
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Histology of thigh muscle
Time Frame: 1 week post intervention
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Muscle biopsy sampled from the vastus lateralis muscle, with a Bergstroem needle with manual suction.
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1 week post intervention
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Body composition: Intraabdominal visceral fat
Time Frame: 1 week pre intervention
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Amount of visceral fat intraabdominally, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
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1 week pre intervention
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Body composition: Intraabdominal visceral fat
Time Frame: 1 week post intervention
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Amount of visceral fat intraabdominally, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
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1 week post intervention
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Body composition: Abdominal subcutaneous fat
Time Frame: 1 week pre intervention
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Amount of subcutaneous fat in the abomen region, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
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1 week pre intervention
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Body composition: Abdominal subcutaneous fat
Time Frame: 1 week post intervention
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Amount of subcutaneous fat in the abomen region, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
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1 week post intervention
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Body composition: Hepatic fat
Time Frame: 1 week pre intervention
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Amount of hepatic fat (%), as measured on a MRI scan fromof the liver with Dixon sequences.
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1 week pre intervention
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Body composition: Hepatic fat
Time Frame: 1 week post intervention
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Amount of hepatic fat (%), as measured on a MRI scan fromof the liver with Dixon sequences.
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1 week post intervention
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Body composition: Fat mass
Time Frame: 1 week pre intervention
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Body fat mass (%) will be analyzed on a whole-body DEXA scan
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1 week pre intervention
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Body composition: Fat mass
Time Frame: 1 week post intervention
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Body fat mass (%) will be analyzed on a whole-body DEXA scan
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1 week post intervention
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Body composition: Fat free mass
Time Frame: 1 week pre intervention
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Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan
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1 week pre intervention
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Body composition: Fat free mass
Time Frame: 1 week post intervention
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Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan
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1 week post intervention
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Body composition: Android-gynoid ratio
Time Frame: 1 week pre intervention
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Android-gynoid ratio will be calculated, as a ratio of the fat mass in the abdominal region and the fat mass in the hip area, obtained by a whole-body DEXA scan
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1 week pre intervention
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Body composition: Android-gynoid ratio
Time Frame: 1 week post-intervention
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Android-gynoid ratio will be calculated, as a ratio of the fat mass in the abdominal region and the fat mass in the hip area, obtained by a whole-body DEXA scan
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1 week post-intervention
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Body composition: Bone mineral density
Time Frame: 1 week pre intervention
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Bone mineral density, will be analyzed on a whole-body DEXA scan.
Z- and T-scores will be calculated.
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1 week pre intervention
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Body composition: Bone mineral density
Time Frame: 1 week post intervention
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Bone mineral density, will be analyzed on a whole-body DEXA scan.
Z- and T-scores will be calculated.
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1 week post intervention
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Body mass index (BMI)
Time Frame: 1 week pre intervention
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BMI will be calculated based on measurements of height and weight.
To measure height the participants will stand up straight against a wall, in bare feet looking straight forward, and will be measured to the nearest 0.1 cm.
Weight will be measured on an automated weight wearing only light indoor clothing with empty pockets and no shoes.
BMI is calculated as wieght in kg diveded by height in meters squared.
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1 week pre intervention
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Body mass index (BMI)
Time Frame: 1 week post intervention
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BMI will be calculated based on measurements of height and weight.
To measure height the participants will stand up straight against a wall, in bare feet looking straight forward, and will be measured to the nearest 0.1 cm.
Weight will be measured on an automated weight wearing only light indoor clothing with empty pockets and no shoes.
BMI is calculated as wieght in kg diveded by height in meters squared.
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1 week post intervention
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Total-cholesterol
Time Frame: 1 week pre intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Total-cholesterol
Time Frame: 1 week post intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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LDL-cholesterol
Time Frame: 1 week pre intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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LDL-cholesterol
Time Frame: 1 week post intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Adipokines: Adiponectin
Time Frame: 1 week pre intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Adipokines: Adiponectin
Time Frame: 1 week post intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Adipokines: Leptin
Time Frame: 1 week pre intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Adipokines: Leptin
Time Frame: 1 week post intervention
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Will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Growth factors
Time Frame: 1 week pre intervention
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Growth factors, i.e.
IGF-1 and IGFBP-3, will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Growth factors
Time Frame: 1 week post intervention
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Growth factors, i.e.
IGF-1 and IGFBP-3, will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Thyroid hormones
Time Frame: 1 week pre intervention
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Thyroid hormones, free triiodothyronine (T3) and thyroxine (T4) as well as thyroid stimulating hormone (TSH) will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Thyroid hormones
Time Frame: 1 week post intervention
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Thyroid hormones, triiodothyronine (T3) and thyroxine (T4) as well as thyroid stimulating hormone (TSH) will be analyzed in a plasma sample.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Sex hormones
Time Frame: 1 week pre intervention
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Analyses of sex hormones, including testosterone and estrogen levels.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Sex hormones
Time Frame: 1 week post intervention
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Analyses of sex hormones, including testosterone and estrogen levels.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Markers of inflammation
Time Frame: 1 week pre intervention
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Analyses of markers of inflammation, including high sensitivity CRP and IL-6 levels.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week pre intervention
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Markers of inflammation
Time Frame: 1 week post intervention
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Analyses of markers of inflammation, including high sensitivity CRP and IL-6 levels.
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
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1 week post intervention
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Oral glucose tolerance test: Glucose
Time Frame: 1 week pre intervention
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Analyses of plasma glucose levels during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: Glucose
Time Frame: 1 week post intervention
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Analyses of plasma glucose levels during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Oral glucose tolerance test: Insulin
Time Frame: 1 week pre intervention
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Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: Insulin
Time Frame: 1 week post intervention
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Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Oral glucose tolerance test: C-peptide
Time Frame: 1 week pre intervention
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Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: C-peptide
Time Frame: 1 week post intervention
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Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Oral glucose tolerance test: Gut hormones
Time Frame: 1 week pre intervention
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Analyses of plasma levels of gut hormones, including GLP-1, GIP and glucagon during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: Gut hormones
Time Frame: 1 week post intervention
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Analyses of plasma levels of gut hormones, including GLP-1, GIP and glucagon during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Oral glucose tolerance test: Bone remodeling markers
Time Frame: 1 week pre intervention
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Analyses of plasma levels of bone remodeling markers, including CTX and P1NP during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: Bone remodeling markers
Time Frame: 1 week post intervention
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Analyses of plasma levels of bone remodeling markers, including CTX and P1NP during a 3 hour oral glucose tolerance test.
Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Health related quality of life - SF36
Time Frame: 1 week pre intervention
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Measure of health related quality of life, by the validated questionnaire SF-36.
Outcome will be total score based o the questionnaire.
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1 week pre intervention
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Health related quality of life - SF36
Time Frame: 1 week post intervention
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Measure of health related quality of life, by the validated questionnaire SF-36.
Outcome will be total score based o the questionnaire.
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1 week post intervention
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Accelerometry using actigraph
Time Frame: 1 week pre intervention
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measure of physical activity and sedentary behavior measured over 7 days recorded as counts per day
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1 week pre intervention
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Accelerometry using actigraph
Time Frame: 1 week post intervention
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measure of physical activity and sedentary behavior measured over 7 days recorded as counts per day and minutes in moderate to vigorous activity
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1 week post intervention
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Oral glucose tolerance test: Matsuda Index
Time Frame: 1 week pre intervention
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Based on glucose and insulin values from the OGTT the Matsuda Index will be calculated, as a measure of peripheral insulin sensitivity.
For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: Matsuda Index
Time Frame: 1 week post intervention
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Based on glucose and insulin values from the OGTT the Matsuda Index will be calculated, as a measure of peripheral insulin sensitivity.
For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Oral glucose tolerance test: Insulinogenic Index
Time Frame: 1 week pre intervention
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Based on glucose and insulin values from the OGTT the insulinogenic Index will be calculated, as a measure of beta-cell function.
For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week pre intervention
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Oral glucose tolerance test: Insulinogenic Index
Time Frame: 1 week post intervention
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Based on glucose and insulin values from the OGTT the insulinogenic Index will be calculated, as a measure of beta-cell function.
For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
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1 week post intervention
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Glucose Metabolism Disorders
- Insulin Resistance
- Hyperinsulinism
- Nutritional and Metabolic Diseases
- Cardiovascular Diseases
- Metabolic Syndrome
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- STEPS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
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Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
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Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
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Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
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Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
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Hospital Mutua de TerrassaCompleted
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IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
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Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
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Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
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Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
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Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States
Clinical Trials on Strength training
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University of AarhusUnknownOsteoarthritis, KneeDenmark
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University of FloridaCompleted
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Universidad Autónoma de Manizales, ColombiaCompletedFemale | Volleyball | PlayerColombia
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Norwegian University of Science and TechnologyCompleted
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Lislei Jorge PatrizziCompleted
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Eunice Kennedy Shriver National Institute of Child...Shriners Hospitals for Children; University of DelawareUnknownSpastic Diplegic Cerebral PalsyUnited States
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University of VigoNot yet recruitingPatients | Cancer Survivors | NeoplamsSpain
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Christian DallCompletedHeart Failure | Ischemic Heart Disease | Heart Transplant RecipientsDenmark
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Isra UniversityCompleted
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Vrije Universiteit BrusselRecruitingHealthy Aged VolunteersBelgium