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NCT00589498 · ClinicalTrials.gov registry record · Phase 3
Fat Gain and Cardiovascular Disease Mechanisms
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
NCT00589498: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT00589498 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 69 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589498, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
Study Summary
Understanding the mechanisms of obesity-induced hypertension is important both for prevention and therapy. Studies of patients with established obesity have provided valuable information on pathophysiologic links between obesity and both blood pressure and cardiovascular risk. However, these studies are necessarily limited by the heterogeneity of obesity-associated disease so that the relative contribution of obesity or hypertension or other co-existing diseases to specific regulatory abnormalities is often not clear. Clarification of whether any abnormalities associated with increased cardiovascular risk were present before or after the development of obesity has also been problematic. We therefore propose a series of novel studies directed at establishing the effects of increased body fat in otherwise healthy individuals. We will determine the distribution patterns of increased body fat and how both increased body fat and fat distribution relate to changes in blood pressure, and in neural, endothelial and inflammatory mechanisms which have been implicated in the development and progression of cardiac and vascular disease. We will study non-obese subjects with and without a family history of hypertension. These subjects will undergo an eight-week program of overfeeding with the objective of inducing a 4 kg fat gain. We will determine the nature of fat distribution in these individuals after the fat gain program and subsequently after an eight-week period of weight loss and restoration of normal body weight. Measurements will be compared to those obtained in a matched control group with and without a family history of hypertension, who will continue their normal diets. We will test the following hypotheses: * Individuals with a family history of hypertension will gain more visceral fat and upper body subcutaneous fat and will have greater blood pressure increases with overfeeding- compared with those without such a family history. * For all overfed subjects, incr
Interventions
- DIETARY_SUPPLEMENT 1000 extra calories
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2005-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00589498
The ClinicalTrials.gov registry entry for NCT00589498 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 1000 extra calories is the first listed.
NCT00589498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00589498 about?
NCT00589498 is a clinical study titled "Fat Gain and Cardiovascular Disease Mechanisms". Understanding the mechanisms of obesity-induced hypertension is important both for prevention and therapy. Studies of patients with established obesity have provided valuable information on pathophysiologic links between obesity and both blood pressure and cardiovascular risk. However, these studies...
What is the current status of trial NCT00589498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2005-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00589498?
The interventions under investigation include: 1000 extra calories (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00589498?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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