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NCT00535535 · ClinicalTrials.gov registry record · Phase 1
Fructose-Induced Palmitate Synthesis in Overweight Subjects
A Phase 1 study of Diabetes and Cardiovascular Disease, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00535535: Completed Phase 1 study of Diabetes and Cardiovascular Disease, sponsored by Rockefeller University.
NCT00535535 is a Phase 1 study of Diabetes and Cardiovascular Disease that has completed, run by Rockefeller University. The registered enrollment target is 15 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00535535, a Phase 1 study of Diabetes and Cardiovascular Disease, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver from each single oral dose of fructose (0.5 g/kg), fructose:glucose 1:1 (1 g/kg) or fructose:glucose 1:1 (2 g/kg). Our hypotheses are that the synthesis of palmitate from dietary fructose will be 1) greater when consumed with glucose and 2) show a dose-response. The lipogenic responses will be compared and correlated with markers of carbohydrate and lipid flux measured after fasting and post-fructose. The results will serve as a guide to the development of a new outpatient probe of the de novo lipogenic pathway in subjects who vary in their lipogenic response to oral fructose. These studies should ultimately yield valuable new information about the mechanisms linking dietary carbohydrate to elevated triglycerides, diabetes and cardiovascular disease.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Fructose
- DIETARY_SUPPLEMENT Fructose and Glucose
Study Locations (1)
New York
- Rockefeller University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT00535535 record still lists
NCT00535535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Fructose is the first listed.
NCT00535535 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00535535 about?
NCT00535535 is a clinical study titled "Fructose-Induced Palmitate Synthesis in Overweight Subjects". Dietary fructose potently exacerbates the dyslipidemia associated with obesity, insulin resistance and accelerated atherosclerosis. In a randomized crossover outpatient study of 15 overweight adults, we will measure the increase over 4 hours in serum VLDL triglyceride palmitate made by the liver fro...
What is the current status of trial NCT00535535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2007-08. Estimated completion is 2011-12.
What conditions does trial NCT00535535 study?
This clinical trial studies the following conditions: Diabetes, Cardiovascular Disease, Elevated Triglycerides.
What interventions are being tested in trial NCT00535535?
The interventions under investigation include: Fructose (DIETARY_SUPPLEMENT), Fructose and Glucose (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00535535?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00535535 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00535535's enrollment target sits among peer trials
15 323rd of 338 higher than 15 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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