Incretin Effect in People With Impaired Fasting Glucose
- Registration Number
- NCT00795275
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose <5.6 mmol/l and 2h OGTT <7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT <7.8 mmol/l).
Exclusion Criteria
- Subjects were excluded for: thyroid stimulating hormone <50 or >500 milliunits/L, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2 times normal), hematocrit < 38%, or white blood cell count <3.0 x 103. Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI <25 or >40 kg/m2. Diabetes or impaired glucose tolerance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Impaired Fasting Glucose Sitagliptin Phosphate Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) Normal glucose tolerance Sitagliptin Phosphate Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)
- Primary Outcome Measures
Name Time Method Change in Insulin Secretion Baseline and 28 days Change in Endogenous Glucose Production Baseline and 28 days
- Secondary Outcome Measures
Name Time Method Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1 Baseline and 28 days Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon Baseline and 28 days Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide Baseline and 28 days Insulin Secretion in Response to Oral vs. IV Glucose Baseline Baseline and Change in Hormones, Substrates and Insulin Action: Lactate Baseline and 28 days Baseline and Change in Hormones, Substrates and Insulin Action: FFA Baseline and 28 days Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol Baseline and 28 days
Trial Locations
- Locations (1)
University of Colorado Denver
🇺🇸Aurora, Colorado, United States