Status:
COMPLETED
Sitagliptin and Brown Adipose Tissue
Lead Sponsor:
Ingrid Jazet
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Neoplasms, Adipose Tissue
Eligibility:
MALE
35-50 years
Phase:
PHASE4
Brief Summary
The obesity epidemic has resulted in an exponential increase in obesity-related disorders including type 2 diabetes, dyslipidemia and cardiovascular disease. The associated morbidity and mortality hav...
Detailed Description
In the current study, the effect of 12 weeks of STG treatment (100 mg/day p.o.) versus placebo will be studied in moderately obese pre-diabetic Dutch Caucasians males (35-50 years). All study subject...
Eligibility Criteria
Inclusion
- Male volunteers, Caucasians, born in the Netherlands
- Age: 35-55 years
- BMI \> 25 and \< 32 kg/m2
- plasma glucose levels 2 h after OGTT between 7.8 and 11 mM (e.g. impaired glucose tolerance)
Exclusion
- Diabetes mellitus (determined on basis of oral glucose tolerance test (OGTT)) defined by ADA criteria
- BMI \> 30 kg/m2 or \< 25 kg/m2
- plasma glucose levels 2 h after OGTT \< 7.8 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 start of the study
- difficulties to insert an intravenous catheter
- recent participation in other research projects (within the last 3 months)
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02294084
Start Date
March 1 2014
End Date
December 1 2016
Last Update
July 16 2018
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA