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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: Completed NA study of Obesity, sponsored by Nemours Children's Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Value at 6 months minus value at baseline. HsCRP is an acute phase protein which is a sensitive marker for systemic inflammation. HsCRP concentrations were measured in our laboratory by immuno-nephelometry (Siemens Healthcare Diagnostics, Deerfield IL, USA), with an hsCRP lower sensitivity of 0.156 mg/L.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2003-11 |
| Est. Completion | 2011-09 |
| Phase | NA |
What the finished NCT00139477 record still lists
NCT00139477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00139477's enrollment target sits among peer trials
66 616th of 1053 higher than 433 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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