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Incretin Effect in People With Impaired Fasting Glucose (1651)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00795275
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : December 31, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Januvia (sitagliptin phosphate) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Incretin Effect in People With IFG
Study Start Date : January 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Baseline and change in endogenous glucose production [ Time Frame: 28 days ]
  2. Baseline and change in insulin secretion [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Insulin secretion in response to oral vs. IV glucose [ Time Frame: baseline ]
  2. Baseline and change in hormones, substrates and insulin action [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00795275

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT00795275     History of Changes
Other Study ID Numbers: 07-0749
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: November 2008
Keywords provided by University of Colorado, Denver:
insulin secretion
insulin action
simple obesity
impaired fasting glucose
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action