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NCT00738023 · ClinicalTrials.gov registry record · Phase 4
Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT00738023: Completed Phase 4 study, sponsored by Emory University.
NCT00738023 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00738023, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin to increase FFA \~ four-fold-baseline levels for 48 hours results in a significant and reproducible raise in systolic and diastolic blood pressure (BP) in obese African American subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known effect on insulin resistance, sustained elevation of FFA results in the development of an acute metabolic syndrome.
Primary Outcome
Systolic blood pressure change from baseline during an 48-hour intralipid infusion
Interventions
- DRUG Rosiglitazone
- DRUG Intralipid 20%
- DRUG Normal saline 0.9%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2004-03 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00738023 record still lists
NCT00738023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Rosiglitazone is the first listed.
NCT00738023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00738023 about?
NCT00738023 is a clinical study titled "Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes". Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese...
What is the current status of trial NCT00738023?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2004-03. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00738023?
The interventions under investigation include: Rosiglitazone (DRUG), Intralipid 20% (DRUG), Normal saline 0.9% (DRUG).
Who is sponsoring clinical trial NCT00738023?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00738023's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 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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