The effect of sitagliptin on brown adipose tissue and whole-body metabolism in overweight pre-diabetic me
- Conditions
- Type 2 diabetes10018424
- Registration Number
- NL-OMON44534
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- Male volunteers, 30 Caucasians, born in the Netherlands
- Age: 35-55 years
- BMI * 25 and * 35 kg/m2
- Plasma glucose levels 2 h after OGTT between 7.8 and 11 mM (e.g. impaired glucose tolerance) or fasted plasma glucose >5.6 mM
- Diabetes mellitus (determined on basis of oral glucose tolerance test (OGTT) defined by ADA criteria
- BMI > 35 kg/m2 or < 25 kg/m2
- Plasma glucose levels 2 h after OGTT < 7.8 mM or > 11.1 mM
- Use of medication known to influence glucose and/or lipid metabolism or BAT activity (e.g. beta blockers)
- Any significant chronic disease
- Renal, hepatic or endocrine disease
- Smoking
- Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
- Difficulties to insert an intravenous catheter
- Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of sitagliptin treatment on BAT activity (measured via<br /><br>cold-induced 18F-FDG PET-CT scans)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the effect of sitagliptin treatment on 1) resting energy expenditure,<br /><br>2) muscle glucose metabolism, 3) fat mass, 4) glucose metabolism, and 5) plasma<br /><br>lipid levels in overweight, pre-diabetic subjects. </p><br>