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')

The effect of sitagliptin on brown adipose tissue and whole-body metabolism in overweight pre-diabetic men - SitaBAT study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003532-39-NL

Enrollment

Unknown

Registered

2014-10-15

Start date

2014-11-24

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, dyslipidemia and impaired glucose tolerance

Interventions

Trade Name: Januvia (Sitagliptin) Product Name: Januvia (Sitagliptin) Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria: - Diabetes mellitus (determined on basis of oral glucose tolerance test (OGTT) defined by ADA criteria (22) - BMI > 30 kg/m2 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main object of the trial is to evaluate the effect of sitagliptin treatment on BAT activity in overweight, pre-diabetic subjects.;Secondary Objective: The secondary objectives of the study are to assess the effect of sitagliptin treatment on 1) resting energy expenditure, 2) muscle glucose metabolism, 3) fat mass, 4) glucose metabolism and 5) plasma lipid levels in overweight, pre-diabetic subjects;Primary end point(s): BAT volume and activity measured by 18F-FDG PET-CT scan;Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment	—

Measure

Time frame

Main Objective: The main object of the trial is to evaluate the effect of sitagliptin treatment on BAT activity in overweight, pre-diabetic subjects.;Secondary Objective: The secondary objectives of the study are to assess the effect of sitagliptin treatment on 1) resting energy expenditure, 2) muscle glucose metabolism, 3) fat mass, 4) glucose metabolism and 5) plasma lipid levels in overweight, pre-diabetic subjects;Primary end point(s): BAT volume and activity measured by 18F-FDG PET-CT scan;Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment;Secondary end point(s): - Fasted thermoneutral and cold-induced REE by indirect calorimetric - Expression of several biomarkers for insulin signaling and glucose and lipid metabolism in skeletal muscle biopsies measured by RT-PCR and Western Blot - Body weight and fat mass measured by DXA scan - Fasting serum markers for glucose metabolism (glucose, insulin, HbA1c and C-peptide) - Fasting serum markers for lipid metabolism (total cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Before and after 12 weeks of treatment;Secondary end point(s): - Fasted thermoneutral and cold-induced REE by indirect calorimetric - Expression of several biomarkers for insulin signaling and glucose and lipid metabolism in skeletal muscle biopsies measured by RT-PCR and Western Blot - Body weight and fat mass measured by DXA scan - Fasting serum markers for glucose metabolism (glucose, insulin, HbA1c and C-peptide) - Fasting serum markers for lipid metabolism (total cholesterol, HDL-C, LDL-C, triglycerides, free fatty acids)

—

Countries

Netherlands

Contacts

Public ContactClinical Trial Information

Leiden University Medical Center

m.r.boon@lumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026