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NCT00994682 · ClinicalTrials.gov registry record · Phase 4
University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)
A Phase 4 study of Type 2 Diabetes Mellitus and Nonalcoholic Steatohepatitis, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 176
- Enrollment target
- 1
- Study location
NCT00994682 is a Phase 4 study of Type 2 Diabetes Mellitus and Nonalcoholic Steatohepatitis that has completed, run by University of Florida. The registered enrollment target is 176 participants, below the 2,747-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00994682, a Phase 4 study of Type 2 Diabetes Mellitus and Nonalcoholic Steatohepatitis, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 176 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this study is to assess the underlying mechanisms at the clinical and molecular level and the long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups locally) and examine the response including patients with normal glucose tolerance, impaired glucose tolerance or established type 2 diabetes mellitus (T2DM).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pioglitazone study drug
- DRUG Pioglitazone Open Label
Study Locations (1)
Texas
- Bartter Research Unit, Audie L Murphy VA Hospital - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2008-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00994682
The ClinicalTrials.gov registry entry for NCT00994682 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,747-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (94% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00994682 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00994682 about?
NCT00994682 is a clinical study titled "University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)". Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone improves glucose/lipid metabolism and his...
What is the current status of trial NCT00994682?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 176 participants. The study started on 2008-12. Estimated completion is 2014-12.
What conditions does trial NCT00994682 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT00994682?
The interventions under investigation include: Placebo (DRUG), Pioglitazone study drug (DRUG), Pioglitazone Open Label (DRUG).
Who is sponsoring clinical trial NCT00994682?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00994682 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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