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Incretin Effect in People With Impaired Fasting Glucose (1651)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00795275
First received: November 20, 2008
Last updated: December 27, 2012
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Drug: Januvia (sitagliptin phosphate)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploring the Incretin Effect in People With IFG

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Baseline and change in endogenous glucose production [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Baseline and change in insulin secretion [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin secretion in response to oral vs. IV glucose [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Baseline and change in hormones, substrates and insulin action [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFG
people with impaired fasting glucose
 Drug: Januvia (sitagliptin phosphate)
Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Experimental: NGT
people with normal glucose tolerance
 Drug: Januvia (sitagliptin phosphate)
Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 <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 mU/l, fasting triglycerides >10.3 mmol/l, creatinine >130 μmol/l, elevated liver function tests (>2X normal), hematocrit < 38%, or WBC<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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795275

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Leigh Perreault, MD University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00795275     History of Changes
Other Study ID Numbers: 07-0749
Study First Received: November 20, 2008
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
pre-diabetes
isotopes
insulin secretion
insulin action
 GLP-1
simple obesity
impaired fasting glucose

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Incretins
Sitagliptin
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents

ClinicalTrials.gov processed this record on June 18, 2013