The effect of the diabetes medication sitagliptin on brown fat and whole-body metabolism in men with overweight and impaired glucose tolerance (or 'pre-diabetes')

Phase 1

• Conditions: Obesity, dyslipidemia and impaired glucose tolerance; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003532-39-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-15
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Male volunteers, 30 Caucasians, born in the Netherlands
- Age: 35-50 years
- BMI = 25 and = 30 kg/m2
- Plasma glucose levels 2 h after OGTT between 7.8 and 11 mM (e.g. impaired glucose tolerance)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Diabetes mellitus (determined on basis of oral glucose tolerance test (OGTT) defined by ADA criteria (22)
- BMI > 30 kg/m2 or < 25 kg/m2
- Plasma glucose levels 2 h after OGTT < 7.8 mM or > 11,1
- 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 clinical trial of medicinal product
• Study Design: Not specified