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van CCT (UK)

van CCT (UK)

The effect of insulin resistance on brown adipose tissue activity.

- candidate number13136
- NTR NumberNTR3523
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jul-2012
- Secondary IDs12-3-010 / NL39816.068.12; METC MUMC / CCMO
- Public TitleThe effect of insulin resistance on brown adipose tissue activity.
- Scientific TitleThe effect of fasting-induced insulin resistance on brown adipose tissue activity, non-shivering thermogenesis and skeletal muscle mitochondrial uncoupling.
- hypothesisWe hypothesise that fasting-induced insulin resistance will result in decreased glucose uptake and activity of brown adipose tissue (BAT). In addition, prolonged fasting will lead to reduced mitochondrial uncoupling in skeletal muscle, which is accompanied by reduced non-shivering thermogenesis.
- Healt Condition(s) or Problem(s) studiedBrown adipose tissue, Insulin resistance, Skeletal muscle, Non-shivering
- Inclusion criteria1. BMI: 18-25 kg/m2;
2. Age: 18-30 years;
3. For females: specific oral contraceptive;
4. Caucasians;
5. Good general health;
6. Sedentary (<2 times/week or <3 hours/week sports).
- Exclusion criteria1. Diabetes mellitus;
2. Elevated fasting blood glucose levels (>5.6 mmol/l);
3. Cardiovascular diseases;
4. Use of beta-blockers;
5. Asthma or other obstructive pulmonary diseases;
6. Hyperthyroidism;
7. For females: pregnancy;
8. Participation in earlier research that included a PET/CT scan;
9. Radiation therapy due to medical treatment.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate1-nov-2013
- Target number of participants18
- InterventionsVolunteers will undergo 2 FDG PET/CT scans of the upper body to determine BAT glucose uptake rate during mild cold exposure. One scan will be performed during a normal-fed period (after 6 hours of fasting). The second scan will be performed after a 55-hour fasting period, which is used to induce an insulin resistant state in otherwise healthy volunteers. To investigate the role of skeletal muscle mitochondrial uncoupling in non-shivering thermogenesis, muscle biopsies will be taken during the normal-fed period and after the prolonged fasting period.
- Primary outcome1. Standard Uptake Values (SUV) of FDG in active BAT, as measured using FDG PET/CT scans (normal-fed period vs. prolonged fasting period);
2. Energy expenditure, as measured using indirect calorimetry, during thermoneutral and mild cold conditions (normal-fed period vs. prolonged fasting period);
3. Skeletal muscle mitochondrial uncoupling, as measured using high-resolution respirometry, in muscle biopsies (normal-fed period vs. prolonged fasting period);
4. Ex vivo skeletal muscle insulin-stimulated glucose uptake, as a measure of insulin sensitivity (normal-fed period vs. prolonged fasting period).
- Secondary outcome1. Skin temperatures and core temperature during thermoneutral and mild cold conditions (normal-fed period vs. prolonged fasting period);
2. Skin perfusion, using Laser Dopller Flowmetry (normal-fed period vs. prolonged fasting period);
3. Blood parameters, among others insulin, glucose, free fatty acids, catecholamines and thyroid hormones, during thermoneutral and mild cold conditions (normal-fed period vs. prolonged fasting period).
- TimepointsParticipation will take approximately 64 hours.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESPhD. Wouter Marken Lichtenbelt, van
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
European Union
- Publications
- Brief summaryBrown adipose tissue (BAT) activity is considered an imporant heat-producing mechanism during the process of non-shivering thermogenesis during mild cold exposure. The most common method to measure BAT activity is to measure its glucose uptake rate (by means of FDG PET/CT scanning). Human and animal studies have suggested an important role for insulin and insulin sensitivity in glucose uptake in BAT. We hypothesize that in an insulin resistant state BAT glucose uptake is impaired, causing a decrease in BAT activity.
- Main changes (audit trail)
- RECORD12-jul-2012 - 27-jul-2012

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