Diabetes Mellitus, Type 2 Clinical Trial
— RESTOREOfficial title:
Exercise to Restore 24h Rhythmicity in Substrate Metabolism of Prediabetes Subjects
Verified date | May 2023 |
Source | Maastricht University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the effect of exercise training on 24h rhythms in substrate metabolism in overweight subjects with impaired glucose tolerance. Subjects will perform exercise training for 12 weeks. Before and after the exercise period, they will be admitted to research facilities for 45 hours to assess 24h rhythms in substrate metabolism. In a single-arm longitudinal design, subjects will serve as their own control.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 24, 2023 |
Est. primary completion date | December 22, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 75 Years |
Eligibility | Inclusion Criteria: - Caucasian - Healthy (as determined by dependent physician) - Overweight: BMI 25 - 35 kg/m2 - Prediabetic based on one or a combination of the following criteria: - Impaired Glucose Tolerance (IGT): plasma glucose values = 7.8 mmol/l and = 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening. - Impaired Fasting Glucose (IFG): Fasting plasma glucose = 6.1 mmol/l and = 6.9 mmol/l. - Insulin Resistance: glucose clearance rate = 360ml/kg/min, as determined using the OGIS120 model. - HbA1c of 5.7-6.4%. - Regular sleeping time (normally 7 - 9h daily) - Stable dietary habits: no weight gain or loss > 3kg in the last three months. Exclusion Criteria: - Use of anticoagulants - Previously diagnosed with type 2 diabetes - Current alcohol consumption > 20 grams alcohol/day - Extreme early bird or extreme night person (score = 30 or = 70 on MEQ-SA questionnaire) - Heavily varying sleep-wake rhythm - Nightshift work during last 3 months - Travel across > 1 time zone in the last 3 months - Significant food allergies/intolerance (seriously hampering study meals) - Using > 400mg caffeine daily (more than 4 coffee or energy drink) - Smoking |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 24 rhythm in whole-body energy metabolism (energy expenditure) | Energy expenditure (kJ/min) measured by indirect calorimetry | measured at 8:00, 13:00, 18:00, 23:00, 04:00 of the main test day before and after 12 weeks of exerise | |
Primary | Change in 24 rhythm in whole-body energy metabolism (glucose oxidation) | Energy expenditure (kJ/min) measured by indirect calorimetry | measured at 8:00, 13:00, 18:00, 23:00, 04:00 of the main test day before and after 12 weeks of exercise | |
Primary | Change in 24 rhythm in whole-body energy metabolism (fat oxidation) | Energy expenditure (kJ/min) measured by indirect calorimetry | measured at 8:00, 13:00, 18:00, 23:00, 04:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24 rhythm in skeletal muscle mitochondrial respiration | O2-flux (pmol/mg/s) measured with high resolution respirometry | measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in muscle protein levels of markers involved in molecular clock and mitochondrial metabolism | Quantify protein levels by Western blots | measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in muscle DNA of markers involved in molecular clock and mitochondrial metabolism | Quantify DNA by qPCR | measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in muscle DNA involved in molecular clock and mitochondrial metabolism. | Quantify DNA by micro-array | measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in muscle mRNA markers involved in molecular clock and mitochondrial metabolism | Quantify mRNA levels by micro array | measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24 rhythm of markers of normal 24h rhythm (cortisol) | Blood cortisol levels | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24 rhythm of markers of normal 24h rhythm (melatonin) | Blood melatonin levels | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24 rhythm of markers of normal 24h rhythm (core body temperature) | Core body temperature measured by an ingested telemetric pill | measured continuously for 24 hours on the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in serum glucose | Serum glucose levels determined from venous blood draws | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in serum insulin | Serum insulin levels determined from venous blood draws | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in serum free fatty acids (FFA) | Serum FFA levels determined from venous blood draws | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in serum triglycerides | Serum triglycerides levels determined from venous blood draws | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise | |
Secondary | Change in 24h rhythm in serum cholesterol | Serum cholesterol levels determined from venous blood draws | every two hours for 24 hours beginning at 08:00 of the main test day before and after 12 weeks of exercise |
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