Incretin Effect in People With Impaired Fasting Glucose

NCT00795275 | Completed Results

• 1 other identifier: 07-0749
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Endogenous Glucose Production

  Baseline and 28 days

• Change in Insulin Secretion

  Baseline and 28 days

Secondary Outcomes (7)

• Insulin Secretion in Response to Oral vs. IV Glucose

  Baseline

• Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide

  Baseline and 28 days

• Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon

  Baseline and 28 days

• Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1

  Baseline and 28 days

• Baseline and Change in Hormones, Substrates and Insulin Action: Lactate

  Baseline and 28 days

Study Arms (2)

Impaired Fasting Glucose

EXPERIMENTAL

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

Drug: Sitagliptin Phosphate

Normal glucose tolerance

EXPERIMENTAL

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

Drug: Sitagliptin Phosphate

Interventions

Sitagliptin Phosphate DRUG

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

Also known as: brand name: Januvia

Impaired Fasting Glucose; Normal glucose tolerance

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 20708814 DERIVED

MeSH Terms

Conditions

Obesity; Glucose Intolerance

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Leigh Perreault, MD
• Organization: University of Colorado Anschutz Medical Campus

leigh.perreault@ucdenver.edu

303-249-7732

Study Officials

• Leigh Perreault, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)