Incretin Effect in People With Impaired Fasting Glucose (1651)

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ClinicalTrials.gov Identifier: NCT00795275

Recruitment Status : Completed

First Posted : November 21, 2008

Last Update Posted : December 31, 2012

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

Study Description

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

Study Design

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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

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Baseline and change in endogenous glucose production [ Time Frame: 28 days ]
Baseline and change in insulin secretion [ Time Frame: 28 days ]

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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

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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 ClinicalTrials.gov identifier (NCT number): NCT00795275

Locations

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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

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Principal Investigator:	Leigh Perreault, MD	University of Colorado, Denver

More Information

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

Perreault L, Man CD, Hunerdosse DM, Cobelli C, Bergman BC. Incretin action maintains insulin secretion, but not hepatic insulin action, in people with impaired fasting glucose. Diabetes Res Clin Pract. 2010 Oct;90(1):87-94. doi: 10.1016/j.diabres.2010.06.012. Epub 2010 Aug 13.

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Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov 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:


pre-diabetes isotopes insulin secretion insulin action	GLP-1 simple obesity impaired fasting glucose

Additional relevant MeSH terms:

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

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