Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 Non-alcoholic Fatty Liver Disease, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 176
- Enrollment target
- 1
- Study location
NCT00994682: Completed Phase 4 study of Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease, sponsored by University of Florida.
NCT00994682 is a Phase 4 study of Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease that has completed, run by University of Florida. The registered enrollment target is 176 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00994682, a Phase 4 study of Type 2 Diabetes Mellitus and Non-alcoholic Fatty Liver Disease, 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).
Primary Outcome
Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 . The scoring system is based on the following grading: Steatosis: 0 = \<5%; 1 = 5-33%; 2 = \>33-66%; 3 = \>66%. Lobular Inflammation: 0 = No f
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 |
What the finished NCT00994682 record still lists
NCT00994682 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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, Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis.
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.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00994682's enrollment target sits among peer trials
176 43rd of 130 higher than 88 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
ACTIVE NOT RECRUITING · Phase 4
-
Does Pioglitazone Increase the Production of 15-EPI-Lipoxin A4?
COMPLETED · Phase 4
-
Adding Liraglutide to High Dose Insulin: Breaking the Cycle
COMPLETED · Phase 4
-
Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
COMPLETED · Phase 4
-
Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes
COMPLETED · Phase 4
-
Effect Of Exenatide Treatment on Liver Fat Content in Patients With Diabetes
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03304821 · 176 participants · Phase 2
Granulocyte-Macrophage Stimulating Factor (GM-CSF) in Peripheral Arterial Disease
- NCT03447938 · 176 participants · NA
The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial
- NCT03824145 · 176 participants · NA
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
- NCT04177914 · 176 participants · Phase 3
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia