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NCT01040819 · ClinicalTrials.gov registry record · Phase 4
Does Pioglitazone Increase the Production of 15-EPI-Lipoxin A4?
A Phase 4 study of Type 2 Diabetes Mellitus, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT01040819: Completed Phase 4 study of Type 2 Diabetes Mellitus, sponsored by Baylor College of Medicine.
NCT01040819 is a Phase 4 study of Type 2 Diabetes Mellitus that has completed, run by Baylor College of Medicine. The registered enrollment target is 25 participants, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01040819, a Phase 4 study of Type 2 Diabetes Mellitus, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study Summary
Type-2 diabetes mellitus is a public health concern. Patients with type 2 diabetes mellitus are at high risk of developing cardiovascular complications. Diabetic patients are two to four-times more likely to develope cardiovascular disease. The mortality of diabetic patients with cardiovascular disease is much higher than in non-diabetic matched patients with cardiovascular disease. Recently, it has become apparent that not all anti-diabetic drugs have the same effect on the progression of atherosclerosis and on cardiovascular outcomes. There is a great need to understand the potential protective mechanisms of the various anti-diabetic drugs in order to decrease their risk for cardiovascular morbidity and mortality. In addition to increasing insulin sensitivity, Pioglitazone (PIO) has anti-inflammatory properties. However, the underlying mechanisms of these anti-inflammatory (and probably anti-atherosclerotic) effects of PIO are unknown. We have shown in the rat that 3-day pretreatment with PIO increases myocardial cyclooxygenase-2 (COX2) activity and levels of both 6-keto-PGF1a, the stable metabolite of prostacyclin (PGI2) and 15-epi-lipoxin A4, a lipid mediator with a strong anti-inflammatory properties. Prostacyclin inhibits platelet aggregation and causes vasodilatation. Increased levels of 6-keto-PGF1a and 15-epi-lipoxin A4 may thus be the explanation for the anti-inflammatory and anti-atherosclerosis effects of PIO. Several clinical studies have shown that COX2 inhibition is associated with increased cardiovascular events. Thus, augmenting COX2 activity and the production of prostacyclin and 15-epi-lipoxin A4 may have potential favorable effects. The purpose of the study is to test whether PIO therapy is associated with an increase in serum and/or urine levels of 6-keto-PGF1a and 15-epi-lipoxin A4 in patients with diabetes mellitus type 2.
Primary Outcome
Plasma 15-epi-LXA4 levels
Conditions Studied
Interventions
- DRUG Pioglitazone
Study Locations (2)
Texas
- Baylor Clinics - Houston
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01040819 record still lists
NCT01040819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Pioglitazone is the first listed.
NCT01040819 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01040819 about?
NCT01040819 is a clinical study titled "Does Pioglitazone Increase the Production of 15-EPI-Lipoxin A4?". Type-2 diabetes mellitus is a public health concern. Patients with type 2 diabetes mellitus are at high risk of developing cardiovascular complications. Diabetic patients are two to four-times more likely to develope cardiovascular disease. The mortality of diabetic patients with cardiovascular dise...
What is the current status of trial NCT01040819?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2010-02. Estimated completion is 2011-12.
What conditions does trial NCT01040819 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01040819?
The interventions under investigation include: Pioglitazone (DRUG).
Who is sponsoring clinical trial NCT01040819?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01040819 being conducted?
This trial has 2 study locations 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 NCT01040819's enrollment target sits among peer trials
25 98th of 130 higher than 31 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.
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