N/A
N=26
Incretin Effect in People With Impaired Fasting Glucose
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00795275 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change in Endogenous Glucose Production — 1.47; 1.46; 1.44; 1.37 mg/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sitagliptin Phosphate (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endogenous Glucose Production |
1.47; 1.46; 1.44; 1.37 | — |
| PRIMARY Change in Insulin Secretion |
104; 97; 75; 71 | — |
| SECONDARY Insulin Secretion in Response to Oral vs. IV Glucose |
— | — |
| SECONDARY Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide |
0.8; 0.7; 0.9; 0.7 | — |
| SECONDARY Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon |
62; 63; 61; 66 | — |
| SECONDARY Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1 |
7.5; 3.4; 8.3; 5.4 | — |
| SECONDARY Baseline and Change in Hormones, Substrates and Insulin Action: Lactate |
0.4; 0.3; 0.4; 0.4 | — |
| SECONDARY Baseline and Change in Hormones, Substrates and Insulin Action: FFA |
604; 610; 631; 547 | — |
| SECONDARY Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol |
91; 85; 93; 85 | — |
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.
Eligibility Criteria
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 500 milliunits/L, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2 times normal), hematocrit 40 kg/m2. Diabetes or impaired glucose tolerance.
Data sourced from ClinicalTrials.gov (NCT00795275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.