Incretin Effect in People With Impaired Fasting Glucose

NCT ID: NCT00795275

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-11-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Impaired Fasting Glucose

Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate)

Group Type: EXPERIMENTAL

Sitagliptin Phosphate

Intervention Type: DRUG

Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

Normal glucose tolerance

Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)

Group Type: EXPERIMENTAL

Sitagliptin Phosphate

Intervention Type: DRUG

Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

Interventions

Sitagliptin Phosphate

Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

Intervention Type: DRUG

Other Intervention Names

brand name: Januvia

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 <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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Perreault, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20708814 (View on PubMed)

Other Identifiers

07-0749

Identifier Type: -

Identifier Source: org_study_id