- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405545
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity
September 13, 2022 updated by: Maastricht University
High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity: Unraveling Health Effects and Underlying Mechanisms
This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
19 overweight-obese (BMI => 27kg/m2), sedentary females and males aged 45-75yr will be enrolled in this study.
Participants will train 3 times/week under supervision during 12 weeks. Before, after and during this 12-week training period, there will be multiple metabolic measurements.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- University Maastricht
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed informed consent
- Age 45 - 75 years old
- Overweight to obese (BMI => 27kg/m2)
- Sedentary - subjects do not perform any regular physical activity weekly(<3 times per week, <150 min/week).
Exclusion Criteria:
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Participation in an intensive weight-loss program or in vigorous exercise program during the last year before starting the study.
- HbA1c > 6.5% and glucose clearance rate >350 ml/kg/min (by OGTT).
- Previously diagnosed with type 2 diabetes
- Active cardiovascular disease. This will be determined by the questionnaires and by screening on medication.
- Use of beta-blockers
- Anticoagulant therapy
- Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
- Abuse of alcohol (> 3 units (1 unit = 10 gr ethanol) per day)
- Any contra-indication to Magnetic Resonance Imaging (MRI) scanning
- Participation in another biomedical study within 1 month before the first study visit, which may interfere with the outcomes of the present study.
- Use of any medication affecting the glucose homeostasis and whole body metabolism or diseases that may significantly interfere with the main aim of the study.
- Chronic renal dysfunction (creatinine >2 increased (normal value 64-104 µmol/l)
- Subjects who do not want to be informed about unexpected medical findings during the screening / study, or do not wish that their physician is informed, cannot participate in the study.
- Subjects will be included only when the dependent medical doctor of this study approves participation after evaluating all data obtained during the screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HIIT
This group of subjects will perform High Intensity Interval training 3x/week for 12 weeks
|
High-intensity interval training is a training of 30 minutes involving 10 bouts of 1 minute high intensity cycling (80-90% of maximum heart rate) interspersed by 2 minutes rest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-oxidative glucose disposal
Time Frame: 9 hours
|
Measured during a 2-step hyperinsulinemic-euglycemic clamp combined with indirect calorimetry
|
9 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal muscle glycogen content
Time Frame: 1 hour
|
Assessed from skeletal muscle biopsies
|
1 hour
|
Skeletal muscle insulin sensitivity
Time Frame: 9 hours
|
Measured during a 2-step hyperinsulinemic-euglycemic clamp
|
9 hours
|
24 hour glycaemic profile
Time Frame: 48 hours
|
continuous glucose monitor
|
48 hours
|
Skeletal muscle mitochondrial function assessed by Magnetic Resonance Spectroscopy Scan using 31P-MRS methodology, based on the phosphocreatine (PCr) recovery kinetics after exercise.
Time Frame: 1 hour
|
The participant is positioned in the scanner with a home-built exercise device to perform consecutive knee-extensions, in which the participant has to lift a weight whilst laying in the scanner (50-60% max leg capacity of the subjects) for 5 minutes.
Scout images of the upper leg are acquired and fine-tuned shimming is applied.
Before, during and after exercise, spectra are acquired every 4 seconds.
The restoration of PCr is driven almost purely by oxidative metabolism, the time to restore the normal amount reflects mitochondrial function (a faster restoration time means better mitochondrial function).
|
1 hour
|
Metabolic Flexibility during exercise assessed by indirect calorimetry.
Time Frame: 30 minutes
|
Participants will undergo a standardized cycling test at low, moderate and high intensity (30%-50%-70%) during 10 minutes each.
Throughout the test, indirect calorimetry will be performed in order to measure changes in substrate oxidation during exercise.
|
30 minutes
|
Ectopic Fat accumulation in the liver assessed by magnetic resonance spectroscopy.
Time Frame: 1 hour
|
Participants will undergo a magnetic resonance spectroscopy scan from which hepatic fat content will be quantified.
In the 1H-MRS spectra, the water signal, that is dominating the proton spectra, will be suppressed using frequency-selective pre-pulse and the spectra will be fitted to quantify the lipid peak.
A separate spectrum will be measured without water suppression to quantify the unsuppressed water signal.
The CH2/Water ratio will be used as parameter of intrahepatic lipid content.
|
1 hour
|
Maximal Acetylcarnitine formation in the upper-leg at rest and after exercise assessed by Magnetic Resonance Spectroscopy Scan
Time Frame: 1 hour
|
Magnetic resonance imaging (MRI) will be used to guide the spectroscopy measurements and fine shimming will be performed to optimize the magnetic field homogeneity within the region of interest.
A volume of interest will be selected within the m.
vastus lateralis from the MRI images and the 1H-MRS spectra will be acquired from this region of interest.
The intensity of the creatine signal will be used as internal reference.
|
1 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of consumption of insulinogenic, CHO-rich drink post-exercise
Time Frame: 12 weeks
|
Investigate whether the consumption of a insulinogenic, CHO-rich drink post-training prevention adverse effects related to blood glucose fluctuation while maintaining the effects of 12 weeks of HIIT on NOGD.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vera Schrauwen-Hinderling, PhD, Maastricht University
- Principal Investigator: Matthijs Hesselink, Prof. PhD., Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 28, 2018
Primary Completion (ACTUAL)
October 1, 2021
Study Completion (ACTUAL)
October 1, 2021
Study Registration Dates
First Submitted
November 14, 2017
First Submitted That Met QC Criteria
January 12, 2018
First Posted (ACTUAL)
January 23, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL62654.068.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 Overweight and Obesity
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
-
University of British ColumbiaTerminatedOverweight and ObesityCanada
-
National Taiwan University HospitalCompleted
Clinical Trials on High-intenstiy interval training
-
University of MichiganCompletedGlucose IntoleranceUnited States
-
Kuopio Research Institute of Exercise MedicineKuopio University Hospital; University of Basel; University of Eastern Finland; Social Insurance Institution, FinlandTerminatedUnstable Angina Pectoris | Acute Myocardial Infarction | Recurrent Myocardial InfarctionFinland
-
Universidad SurcolombianaMaciste Macias; Gilberto AstaizaRecruiting
-
Cairo UniversityKasr El Aini HospitalCompletedDiabetes Mellitus, Type 2Egypt
-
Universidad Santo TomasCompletedMetabolic DiseasesColombia
-
Kaohsiung Medical University Chung-Ho Memorial...Ministry of Science and Technology, TaiwanRecruiting
-
Université de SherbrookeRecruiting
-
Cairo UniversityRecruitingMultiple SclerosisEgypt
-
Riphah International UniversityCompleted
-
Universidad Santo TomasUniversidad del Rosario; Universidad Manuela BeltránCompleted