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NCT00656864 · ClinicalTrials.gov registry record · Phase 4
Pioglitazone Incretin Study
A Phase 4 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00656864 is a Phase 4 study that has completed, run by University of Vermont. The registered enrollment target is 24 participants.
The verdict
NCT00656864, a Phase 4 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-05 |
| Est. Completion | 2010-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00656864
The ClinicalTrials.gov registry entry for NCT00656864 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00656864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00656864 about?
NCT00656864 is a clinical study titled "Pioglitazone Incretin Study". 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 hel...
What is the current status of trial NCT00656864?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2008-05. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00656864?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT00656864?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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