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NCT00816218 · ClinicalTrials.gov registry record · Phase 4
Molecular Mechanisms of Type 2 Diabetes Mellitus
A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 39
- Enrollment target
NCT00816218: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT00816218 is a Phase 4 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 39 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00816218, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 39 participants
- Enrollment target
Study Summary
This project is designed to evaluate the molecular mechanisms involved in the early development of endothelial dysfunction in type 2 diabetic patients. The investigators intend to correlate increases in insulin signaling pathway activity following pioglitazone therapy with improvements in nitric oxide synthase expression in skeletal muscle. In addition, the investigators will evaluate vascular responses and in vivo nitric oxide release during administration of acetylcholine and nitroprusside in patients with type 2 diabetes. Enhanced knowledge of the molecular mechanisms responsible for endothelial dysfunction, an early abnormality in the pathogenesis of atherosclerosis, is critical before novel therapies to arrest or delay the appearance of cardiovascular complications in diabetes can be developed. The investigators intend to recruit fifty type 2 diabetic patients treated with diet alone or diet plus sulfonylureas or meglitinides and add Pioglitazone (45 mg), an insulin sensitizer, for 6 months. In addition to assessment of clinical and metabolic parameters, insulin sensitivity and brachial artery and skin microcirculatory responses to acetylcholine and nitroprusside in combination with simultaneous determination of nitric oxide release will be documented before, 3 and 6 months after Pioglitazone therapy is initiated. Circulating levels of markers of endothelial damage (VCAM, ICAM, selectins), inflammation (C-reactive protein and interleukins), increased coagulability (PAI-1) as well as lipids and apolipoproteins will measured during the study. Skeletal muscle biopsies will be performed during the euglycemic insulin clamp before and 6 months after therapy for measurements of NO synthase activity and key elements of the insulin signal transduction pathway involved in the regulation of glucose metabolism (IRS-1, PI-3 kinase, PI-3 kinase associated with IRS-1 and the mitogenesis MAP-kinase. Type 2 diabetes confers a substantial increase in the risk of cardiovascular
Primary Outcome
Brachial arterial dilation and blood flow
Interventions
- DRUG Pioglitazone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2003-03 |
| Est. Completion | 2008-11 |
| Phase | Phase 4 |
What the finished NCT00816218 record still lists
NCT00816218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Pioglitazone is the first listed.
NCT00816218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00816218 about?
NCT00816218 is a clinical study titled "Molecular Mechanisms of Type 2 Diabetes Mellitus". This project is designed to evaluate the molecular mechanisms involved in the early development of endothelial dysfunction in type 2 diabetic patients. The investigators intend to correlate increases in insulin signaling pathway activity following pioglitazone therapy with improvements in nitric oxi...
What is the current status of trial NCT00816218?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 39 participants. The study started on 2003-03. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00816218?
The interventions under investigation include: Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT00816218?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00816218's enrollment target sits among peer trials
39 1468th of 2000 higher than 525 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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