- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06081387
Study Protocol About the Effect of Training and Vit.D Supplementation on Lipid Profile in Patients With Type 2 Diabetes (DIAVITEX)
The Effect of Concurrent Aerobic and Resistance Training and Vitamin D Supplementation on Lipid Profile in Patients With Type 2 Diabetes: a Study Protocol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Joel Montane, PhD
- Phone Number: 932533256
- Email: joelmm@blanquerna.url.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age more than 40
- Fasting blood glucose higher than 126mg/dL
- Glycosylated haemoglobin lower than 9%
Exclusion Criteria:
- Have performed a regular physical activity during the last six months (especially resistance training)
- Smokers
- Cardiovascular, pulmonary or musculoskeletal diseases
- Allergic or hypersensitive to vitamin D or any excipient of the formulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training and Vitamin D supplementation
Subjects in the vitamin D and resistance training group will take oral capsules containing 5,000 international units of vitamin D every two weeks for four months.
The tablets will be taken with 250 ml of water at lunch.
Sarcoplasm stimulating training system will be used.
This program will run for 15 weeks and three sessions a week.
This exercise plan is designed in three 5-week periods.
In the first week, the movements are as follows: 4 sets of eight repetitions with 20 seconds interval of rest between sets will be performed, with 60% of maximum repetitions.
In the second week, with increasing intensity, the exercise will be performed with 60% 1RM.
The third week, each movement will be performed in 5 sets with 6 repetitions with 20 seconds of rest between Hursts as an interval with 60% of maximum repetitions.
|
Oral capsules containing 5,000 international units of vitamin D every two weeks for four months.
The tablets will be taken with 250 ml of water at lunch.
Other Names:
Sarcoplasm stimulating training system.
This program will run for 15 weeks and three sessions a week.
This exercise plan is designed in three 5-week periods.
Other Names:
|
Placebo Comparator: Training with placebo
Sarcoplasm stimulating training system will be performed.
This program will run for 15 weeks and three sessions a week.
This exercise plan is designed in three 5-week periods.
In the first week, the movements are as follows: 4 sets of eight repetitions with 20 seconds interval of rest between sets will be performed, with 60% of maximum repetitions.
In the second week, with increasing intensity, the exercise will be performed with 60% 1RM.
The third week, each movement will be performed in 5 sets with 6 repetitions with 20 seconds of rest between Hursts as an interval with 60% of maximum repetitions.
This time, instead of taking a vitamin D capsule, capsules made of paraffin oil will be offered.
Capsules designed as a placebo will be indistinguishable in shape and colour from vitamin D capsules.
The tablets will be taken with 250 ml of water at lunch.
|
Sarcoplasm stimulating training system.
This program will run for 15 weeks and three sessions a week.
This exercise plan is designed in three 5-week periods.
Other Names:
Capsules made of paraffin oil, designed as a placebo.
They will be indistinguishable in shape and colour from vitamin D capsules.
The tablets will be taken with 250 ml of water at lunch.
Other Names:
|
Experimental: Vitamin D supplementation
In this group, no exercise program will be performed.
They will take oral capsules containing 5,000 international units of vitamin D every two weeks for four months.
The tablets will be taken with 250 ml of water at lunch.
|
Oral capsules containing 5,000 international units of vitamin D every two weeks for four months.
The tablets will be taken with 250 ml of water at lunch.
Other Names:
|
Placebo Comparator: Placebo
The control group will only take the placebo capsule: capsules made of paraffin oil will be offered.
Capsules designed as a placebo will be indistinguishable in shape and colour from vitamin D capsules.
The tablets will be taken with 250 ml of water at lunch.
|
Capsules made of paraffin oil, designed as a placebo.
They will be indistinguishable in shape and colour from vitamin D capsules.
The tablets will be taken with 250 ml of water at lunch.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA IR)
Time Frame: Beginning of the study and after 4 months
|
HOMA-IR index will be calculated by using formula (HOMA-IR=fasting glucose in mmol/l*fasting insulin in μU/ml/22.5)
to determine insulin resistance
|
Beginning of the study and after 4 months
|
Change in Homeostasis model assessment of β-cell function (HOMA-β)
Time Frame: Beginning of the study and after 4 months
|
The HOMA-B index will be used to quantify the pancreatic beta cells function (HOMA-B360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63)).
|
Beginning of the study and after 4 months
|
Change in serum levels of Hemoglobin A1c.
Time Frame: Beginning of the study and after 4 months
|
Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at initial visit from a fasting blood sample.
|
Beginning of the study and after 4 months
|
Change in serum lipid profile
Time Frame: Beginning of the study and after 4 months
|
Total cholesterol and High-density lipoprotein (HDL) cholesterol and triglyceride levels (mg/dL).
Analysis ill be performed by the fully automatic Mindray BS380 using photometry-fixed time and point turbidimetry.
|
Beginning of the study and after 4 months
|
Change in weight
Time Frame: Beginning of the study and after 4 months
|
Anthropometric measurements (weight in kilograms)
|
Beginning of the study and after 4 months
|
Change in waist circumference
Time Frame: Beginning of the study and after 4 months
|
Anthropometric measurements (waist circumference in centimetre)
|
Beginning of the study and after 4 months
|
Change in Body Mass Index (BMI)
Time Frame: Beginning of the study and after 4 months
|
(BMI [weight and height will be combined to report BMI] in kg/m2
|
Beginning of the study and after 4 months
|
Vitamin D
Time Frame: Beginning of the study
|
Determination of Vitamin D levels in blood (ng/mL)
|
Beginning of the study
|
Vitamin D
Time Frame: End of the study (4 Months)
|
Determination of Vitamin D levels in blood (ng/mL)
|
End of the study (4 Months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic data
Time Frame: Beginning of the study
|
Sociodemographic data (age, sex, ethnicity, occupation, employment status, education level, household income, alcohol intake, smoking status, current medications, family medical history, current medications taken) via questionnaire.
Additionally, participants may be required to list answers to the questions e.g.
list any current medications taken or age.
This will all be measured in the baseline case report form.
|
Beginning of the study
|
Activity degree
Time Frame: Beginning of the study
|
To evaluate the degree of activity, the International Physical Activity Questionnaire (IPAQ) will be administered to measure the physical activity, which through an interview assessing different items will allow to obtain the usual physical activity, being able to classify individuals in sedentary, moderate sedentary or active lifestyles. The IPAQ questionnaires quantifies the activity: "walk", "activities of moderate intensity" and "vigorous intensity activities" assigned to each activity about energy requirements defined in metabolic equivalent tasks (METs), being multiples of the rate of metabolic rate equivalent to kilocalories for a 60 kg. |
Beginning of the study
|
Activity degree
Time Frame: End of the study (4 Months)
|
To evaluate the degree of activity, the International Physical Activity Questionnaire (IPAQ) will be administered to measure the physical activity, which through an interview assessing different items will allow to obtain the usual physical activity, being able to classify individuals in sedentary, moderate sedentary or active lifestyles. The IPAQ questionnaires quantifies the activity: "walk", "activities of moderate intensity" and "vigorous intensity activities" assigned to each activity about energy requirements defined in metabolic equivalent tasks (METs), being multiples of the rate of metabolic rate equivalent to kilocalories for a 60 kg. |
End of the study (4 Months)
|
Psychological Well-being
Time Frame: Beginning of the study
|
The psychological subjective welfare will be measured through the Psychological Well-being Index, which refers to happiness or well-being. A 42-item self-rating scale, which includes six dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. The respondents are asked to indicate on a 6-likert scale the extent to which they agree with each statement. Each dimension may range from 7-42, with higher scores indicating greater psychological well-being. |
Beginning of the study
|
Psychological Well-being
Time Frame: End of the study (4 Months)
|
The psychological subjective welfare will be measured through the Psychological Well-being Index, which refers to happiness or well-being. A 42-item self-rating scale, which includes six dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. The respondents are asked to indicate on a 6-likert scale the extent to which they agree with each statement. Each dimension may range from 7-42, with higher scores indicating greater psychological well-being. |
End of the study (4 Months)
|
Food consumption and adherence to the Mediterranean diet
Time Frame: Beginning of the study
|
A 14-item questionnaire designed to assess adherence to the traditional Mediterranean Diet will be administered.
Values of 0 or 1 are assigned to each item, the maximum adherence to the Mediterranean Diet is indicated by a 14-point score.
A validated food frequency questionnaire with 140 items will also be administered
|
Beginning of the study
|
Food consumption and adherence to the Mediterranean diet
Time Frame: End of the study (4 Months)
|
A 14-item questionnaire designed to assess adherence to the traditional Mediterranean Diet will be administered.
Values of 0 or 1 are assigned to each item, the maximum adherence to the Mediterranean Diet is indicated by a 14-point score.
A validated food frequency questionnaire with 140 items will also be administered
|
End of the study (4 Months)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joel Montane, PhD, Universitat Ramon Llull
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIAVITEX-1.1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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