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NCT00139477 · ClinicalTrials.gov registry record · NA

Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention

A NA study of Obesity, sponsored by Nemours Children's Clinic.

Completed
Registry status
NA
Development phase
66
Enrollment target
1
Study location

NCT00139477 is a NA study of Obesity that has completed, run by Nemours Children's Clinic. The registered enrollment target is 66 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00139477, a NA study of Obesity, has completed, sponsored by Nemours Children's Clinic.

COMPLETED
Registry status
NA
Development phase
66 participants
Enrollment target
1
Study location

Study Summary

In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be measured as well. The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome. The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.

Conditions Studied

Obesity

Interventions

  • DRUG Metformin
  • BEHAVIORAL Dietary modification with caloric restriction
  • BEHAVIORAL Establishment of exercise protocol

Study Locations (1)

Florida

  • Nemours Children's Clinic - Jacksonville

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2003-11
Est. Completion 2011-09
Phase NA

Sponsor

Nemours Children's Clinic

108 total trials

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What the Registry Record Tells You About NCT00139477

The ClinicalTrials.gov registry entry for NCT00139477 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Metformin is the first listed.

NCT00139477 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00139477 about?

NCT00139477 is a clinical study titled "Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention". In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be r...

What is the current status of trial NCT00139477?

This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2003-11. Estimated completion is 2011-09.

What conditions does trial NCT00139477 study?

This clinical trial studies the following conditions: Obesity.

What interventions are being tested in trial NCT00139477?

The interventions under investigation include: Metformin (DRUG), Dietary modification with caloric restriction (BEHAVIORAL), Establishment of exercise protocol (BEHAVIORAL).

Who is sponsoring clinical trial NCT00139477?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00139477 being conducted?

This trial has 1 study location across Florida. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.