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NCT01223196 · ClinicalTrials.gov registry record · Phase 4
Effect of Pioglitazone on TIMP-3 and TACE in Type 2 Diabetes
A Phase 4 study of Type 2 Diabetes, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT01223196: Completed Phase 4 study of Type 2 Diabetes, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01223196 is a Phase 4 study of Type 2 Diabetes that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 60 participants, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01223196, a Phase 4 study of Type 2 Diabetes, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Pioglitazone has been shown to have potent anti-inflammatory as well anti-atherosclerotic effects. However, the mechanisms by which pioglitazone exerts these effects are not clear. The investigators propose that Tissue Inhibitor of MetalloProteinase-3 (TIMP-3) and TNF-alfa converting enzyme (TACE) play a major role in pioglitazone mediated improvement in insulin sensitivity and endothelial function. In animal models, low dose pioglitazone inhibits lesion progression and matrix metalloproteinase expression in advanced atherosclerotic plaques. The investigators believe that a lower dose of Pioglitazone will also have anti-inflammatory effects. Aim: To examine the effect of low dose Pioglitazone (15mg/day) on TIMP and TACE in Pioglitazone mediated improvements in insulin sensitivity. Methods: Thirty subjects with T2DM will participate in following studies: (i) oral glucose tolerance test (OGTT); (ii) Dual energy absorptiometry(DXA) for body fat content, (iv) skeletal muscle biopsy. Subjects will be randomized to receive either placebo or pioglitazone for 24 weeks. The investigators will study the effect of Pioglitazone on (1) TIMP and TACE substrate activity in skeletal muscle, adipose tissue, mononuclear cells, and their relationship to insulin sensitivity and vascular reactivity, other adipocytokines- resistin, TNF-α and Visfatin; (2) markers of inflammation and atherosclerosis- C-reactive protein, VCAM-1 (vascular cell adhesion molecule 1), ICAM-1 (Intercellular Adhesion Molecule 1), endothelin 1, E-selectin, P-selectin, TNFrecI (Tumor Necrosis Factor Receptor I), TNFrecII (Tumor Necrosis Factor Receptor II), IL-6 (Interleukin 6) receptor.
Primary Outcome
Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment. The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pioglitazone
Study Locations (1)
Texas
- Bartter Research Unit , ALM VA Hospital - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01223196 record still lists
NCT01223196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 3,923-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01223196 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01223196 about?
NCT01223196 is a clinical study titled "Effect of Pioglitazone on TIMP-3 and TACE in Type 2 Diabetes". Background: Pioglitazone has been shown to have potent anti-inflammatory as well anti-atherosclerotic effects. However, the mechanisms by which pioglitazone exerts these effects are not clear. The investigators propose that Tissue Inhibitor of MetalloProteinase-3 (TIMP-3) and TNF-alfa converting enz...
What is the current status of trial NCT01223196?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2009-08. Estimated completion is 2011-12.
What conditions does trial NCT01223196 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT01223196?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01223196?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01223196 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
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Where NCT01223196's enrollment target sits among peer trials
60 192nd of 327 higher than 124 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes 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.
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