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The effect of cold acclimation on human brown adipose tissue - a comparative study in obesity and type 2 daibetes


- candidate number15890
- NTR NumberNTR4319
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2013
- Secondary IDsMETC 13-3-037 NL45645.068.13
- Public TitleThe effect of cold acclimation on human brown adipose tissue - a comparative study in obesity and type 2 daibetes
- Scientific TitleTHE EFFECT OF COLD ACCLIMATION ON HUMAN BROWN ADIPOSE TISSUE AND SKELETAL MUSCLE MITOCHONDRIAL UNCOUPLING A COMPARATIVE STUDY IN OBESITY AND TYPE 2 DIABETES
- ACRONYM
- hypothesisChronic cold exposure will increase:
1. Basal metabolism and facultative thermogenesis;
2. Brown adipose tissue activity and volume both in obese and diabetic subjects;
3. Skeletal muscle mitochondrial uncoupling and result in BRITE cell recruitment.
- Healt Condition(s) or Problem(s) studiedThermogenesis, Brown Adipose Tissue, Skeletal muscle, Non-shivering, Diabetes Mellitus, Obesity
- Inclusion criteriaGeneral
1. Male
2. BMI 28-35
3. Age 18-35 for obese and 18-65 for diabetics
4. Caucasians
Obese:
5. Fasting glucose < 6.1 mmol/l
6. No sings of active cardiovascular disease, uncontrolled hypertension, liver or kidney malfunction
Type 2 diabetics:
1. Diagnosed with type 2 DM at least 1.5 years before start of the study
2. Well-controlled T2DM (HbA1C < 8.5%)
3. No sings of active diabetes-related co-morbidities like cardiovascular disease, diabetic foot, polyneuropathy, retinopathy
4. No signs of active uncontrolled hypertension, liver or kidney malfunction
- Exclusion criteria1. Participate in physical activity more than 2x/week
2. Participation in earlier research that included a PET/CT-scan
3. Radiation therapy due to medical treatment
4. Unstable body weight
5. Participation in another biomedical study within 1 month before the first screening visit
4. Use of Beta-blockers;
Type 2 diabetics:
1. Insulin dependent diabetic subjects
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2016
- Target number of participants36
- InterventionsThe volunteers will undergo two PET/CT-scans, in which cold-induced BAT activity will be measured before and after a cold acclimation period of 10 days. To investigate the role of the skeletal muscle mitochondrial uncoupling and BRITE cell recruitment a muscle and fat biopsy sample will be taken prior to the acclimation period and afterwards. Finally, body composition will be determined with a DXA-scan, and skin perfusion and relevant body temperatures will be measured as well. The subjects with type 2 diabetes will undergo a hyperinsulinemic euglycemic clamp to define insulin sensitivity. Cold acclimation is achieved by exposure to an environmental temperature of 10 degrees (cold room) for 10 consecutive days. The first day the subjects will remain in this cold room for 2 hours, the second day for 4 hours and days 3-10 for 6 consecutive hours. The subjects are dressed in t-shirt, shorts and flip flops. For these 6 hours, the subjects are instructed to refrain from physical activity as much as possible. Watching TV and working on a computer are activities that can be done.
- Primary outcome1. Standard uptake values (SUVs) of FDG of active brown adipose tissue with the PET/CT-scans, one time prior and one time post the cold acclimation period (2x 2hour);
2. Energy expenditure with indirect calorimetry, one time prior and one time post the cold acclimation period (3x 3hour);
3. Skeletal muscle mitochondrial uncoupling with the muscle biopsy, one time before and one time post the cold acclimation period (2x 30minutes). BRITE cell recruitment with the fat biopsy, one time prior and one time post the cold acclimation period (2x 30minutes).
4. Glucose infusion rate (ml/h) by hyperinsulinemic euglycemic clamp, one time prior and one time post the cold acclimation period (2x 5hour)
- Secondary outcome1. Body temperatures (core and skin temperatures) with iButtons and a telemetric pill, one time prior and one time post the cold acclimation period;
2. Skin perfusion with laser Doppler flowmetry, one time prior and one time post the cold acclimation period;
3. Blood parameters, among others insulin, glucose, free fatty acids and thyroid hormones, one time prior and post the cold acclimation period;
4. Body composition with a DXA-scan, one time prior and post the cold acclimation period.
- TimepointsParticipation for the obese subjects will take approximately 70 hours. Participation for the type 2 diabetes subjects will take approximately 90 hours
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. Anouk Lans, van der
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Wouter Marken Lichtenbelt, van
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
NWO-TOP grant, EU FP 7
- PublicationsN/A
- Brief summaryThe volunteers will undergo two PET/CT-scans, in which cold-induced BAT activity will be measured before and after a cold acclimation period of 10 days. To investigate the role of the skeletal muscle mitochondrial uncoupling and BRITE cell recruitment a muscle and fat biopsy sample will be taken prior to the acclimation period and afterwards. Finally, body composition will be determined with a DXA-scan, and skin perfusion and relevant body temperatures will be measured as well. The subjects with type 2 diabetes will undergo a hyperinsulinemic euglycemic clamp to define insulin sensitivity.
- Main changes (audit trail)
- RECORD16-dec-2013 - 3-jan-2014


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