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Incretin Effect in People With Impaired Fasting Glucose (1651)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin Phosphate
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring pre-diabetes, isotopes, insulin secretion, insulin action, GLP-1, simple obesity, impaired fasting glucose

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Impaired Fasting Glucose

Normal glucose tolerance

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Endogenous Glucose Production
Change in Insulin Secretion

Secondary Outcome Measures

Insulin Secretion in Response to Oral vs. IV Glucose
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate
Baseline and Change in Hormones, Substrates and Insulin Action: FFA
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol

Full Information

First Posted
November 20, 2008
Last Updated
March 9, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00795275
Brief Title
Incretin Effect in People With Impaired Fasting Glucose
Acronym
1651
Official Title
Exploring the Incretin Effect in People With IFG
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
pre-diabetes, isotopes, insulin secretion, insulin action, GLP-1, simple obesity, impaired fasting glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impaired Fasting Glucose
Arm Type
Experimental
Arm Description
Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate)
Arm Title
Normal glucose tolerance
Arm Type
Experimental
Arm Description
Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)
Intervention Type
Drug
Intervention Name(s)
Sitagliptin Phosphate
Other Intervention Name(s)
brand name: Januvia
Intervention Description
Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
Primary Outcome Measure Information:
Title
Change in Endogenous Glucose Production
Time Frame
Baseline and 28 days
Title
Change in Insulin Secretion
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
Insulin Secretion in Response to Oral vs. IV Glucose
Time Frame
Baseline
Title
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide
Time Frame
Baseline and 28 days
Title
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon
Time Frame
Baseline and 28 days
Title
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1
Time Frame
Baseline and 28 days
Title
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate
Time Frame
Baseline and 28 days
Title
Baseline and Change in Hormones, Substrates and Insulin Action: FFA
Time Frame
Baseline and 28 days
Title
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol
Time Frame
Baseline and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Perreault, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20708814
Citation
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.
Results Reference
derived

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Incretin Effect in People With Impaired Fasting Glucose

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