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Completed

NCT Number: NCT00795275

Incretin Effect in People With Impaired Fasting Glucose

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.

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Key information

Conditions

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

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sitagliptin phosphate

Drug

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

Other names: brand name: Januvia

Primary outcomes

  1. Change in Endogenous Glucose Production

    Time frame: Baseline and 28 days

  2. Change in Insulin Secretion

    Time frame: Baseline and 28 days

Secondary outcomes

  1. Insulin Secretion in Response to Oral vs. IV Glucose

    Time frame: Baseline

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

    Time frame: Baseline and 28 days

  3. Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon

    Time frame: Baseline and 28 days

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

    Time frame: Baseline and 28 days

  5. Baseline and Change in Hormones, Substrates and Insulin Action: Lactate

    Time frame: Baseline and 28 days

  6. Baseline and Change in Hormones, Substrates and Insulin Action: FFA

    Time frame: Baseline and 28 days

  7. Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol

    Time frame: Baseline and 28 days

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Exploring the Incretin Effect in People With IFG

Acronym: 1651

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2008
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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