Expired Study
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South Burlington, Vermont 05403


Purpose:

Incretin hormones are hormones produced by the gut in response to food intake. These hormones help the body to control the metabolism of glucose (sugar). In particular, two incretin hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood glucose levels. This helps the body to metabolize the glucose more effectively, lowering blood sugar levels. GLP-1 and GIP do not work as well in patients with type 2 diabetes (T2DM) as in subjects who do not have diabetes. This study tests whether a medicine called pioglitazone (Actos), which is commonly used to treat T2DM, improves the ability of GIP to increase insulin secretion. To address this question the investigators will recruit patients with T2DM whose diabetes is controlled with either diet and exercise or with metformin (another medicine commonly used to treat T2DM). Subjects will undergo measurement of body fat by DEXA scanning and a series of studies to characterize their metabolism. These studies include an oral glucose tolerance test (a test sometimes used to diagnose diabetes), a mixed-meal challenge (to measure how much GLP-1 and GIP are produced in response to a meal) and measurement of insulin secretion in response to glucose and GIP given through a vein. The investigators will also obtain small samples of fat (from just under the skin of the belly) using a needle to measure levels of the receptor for GIP. Subjects will then be randomly assigned to 12 weeks of treatment with either pioglitazone or matching placebo (an inactive tablet that does not contain medication). The dose of pioglitazone will be increased during the first 4 weeks to the maximum prescribed dose of 45 mg per day. Subjects will be seen every 2-4 weeks during the treatment phase of the study. After 12 weeks of treatment all studies performed at the beginning of the study will be repeated. The pioglitazone treatment will continue until the end of testing, approximately 4 weeks. The results of this study may give us information about why glucose control deteriorates in T2DM. This information might also lead to new ways to prevent or treat T2DM.


Criteria:

Inclusion Criteria: - Type 2 diabetes controlled with diet+exercise or metformin monotherapy - HbA1c less than or equal to 7% - Women will be non-fertile or practicing birth control Exclusion Criteria: - Acute or chronic medical conditions that would contraindicate participation - Class III or IV heart failure - Pregnant or nursing women - Patients taking antidiabetic medications other than metformin, oral or chronic topical steroids, weight loss agents, antipsychotics, or other drugs that could affect insulin sensitivity or secretion. - AST or ALT more than 2.5 times the upper limit of normal - Active alcohol or drug abuse - Weight greater than 300 pounds


Study is Available At:


Original ID:

08-107


NCT ID:

NCT00656864


Secondary ID:

GCRC-962


Study Acronym:


Brief Title:

Pioglitazone Incretin Study


Official Title:

Effects of Pioglitazone on the Regulation of Insulin Secretion in Patients With Type 2 Diabetes


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Vermont


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard E Pratley, MD
Principal Investigator
University of Vermont

Study Dates

Start Date:May 2008
Completion Date:November 2010
Completion Type:Actual
Primary Completion Date:November 2010
Primary Completion Type:Actual
Verification Date:January 2010
Last Changed Date:February 1, 2011
First Received Date:April 7, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in adipocyte GIP receptor mRNA expression levels.
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in the acute insulin response to glucose, insulin sensitivity and the disposition index during the IV glucose tolerance test.
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in insulin secretion during the oral glucose tolerance test and the mixed meal challenge
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in glucose response during the oral glucose tolerance test and mixed meal challenge
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in active GLP-1 in response to the oral glucose tolerance test and the mixed meal challenge
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in active GIP in response to an oral glucose tolerance test and mixed meal challenge
Time Frame:12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in incretin-mediated insulin secretion and receptor regulation of glucose-dependent insulinotropic peptide (GIP) in patients with type 2 diabetes.
Time Frame:12 weeks per subject
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pioglitazone
Description:Starting dose at 15 mg for two weeks, then titrated up to 45 mg in the subsequent 2 weeks.
Arm Name:1
Other Name:Actos (brand name for pioglitazone)
Intervention Type:Drug
Name:Placebo
Description:placebo
Arm Name:2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Placebo arm
Study Arm Type:Active Comparator
Arm Name:1
Description:Pioglitazone arm

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Vermont
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Takeda Global Research & Development Center, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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