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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 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.

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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.

Interventions

  • DIETARY_SUPPLEMENT Fructose
  • DIETARY_SUPPLEMENT Fructose and Glucose

Study Locations (1)

New York

  • Rockefeller University - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2007-08
Est. Completion 2011-12
Phase Phase 1

Sponsor

Rockefeller University

117 total trials

What the Registry Record Tells You About NCT00535535

The ClinicalTrials.gov registry entry for NCT00535535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (100% lower). The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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