Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00287053 · ClinicalTrials.gov registry record · Phase 4
Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation
A Phase 4 study of Healthy, sponsored by Pennington Biomedical Research Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT00287053 is a Phase 4 study of Healthy that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 57 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00287053, a Phase 4 study of Healthy, has completed, sponsored by Pennington Biomedical Research Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the proposed study is to identify the mechanisms responsible for the weight gain associated with Depakote treatment, and to identify methods to prevent and treat weight gain in people taking Depakote. Both sides of the energy balance equation will be measured in a sample of healthy lean and overweight adults. Energy intake will be measured in the Pennington Center's Eating Laboratory, and total daily energy expenditure (TEE) and posture allocation will be measured with the IDEEA™. Questionnaires that assess food cravings and eating attitudes and behaviors will be used to determine if a behavioral phenotype is associated with weight gain in response to Depakote treatment. It is hypothesized that Depakote treatment will result in increased food intake. It is also hypothesized that the time spent engaging in sedentary behavior will increase in response to Depakote treatment. Time spent engaging in, and the energy expended during, physical activity is expected to decrease significantly. Therefore, it is hypothesized that TEE is expected to decrease significantly. The results will be used to identify specific behavioral targets to prevent weight gain during treatment with Depakote. Potential targets include interventions to modify food intake and physical activity. The degree to which each behavior (food intake or physical activity) will be targeted is dependent on the results of this study. For instance, if the majority of the weight gain associated with Depakote treatment is due to changes in food intake, stronger dietary interventions will be suggested. Additionally, changes in endocrine factors (hormones and peptides) will be evaluated during the study to determine if Depakote is associated with an altered endocrine response that affects satiety, food intake, or energy expenditure. If an altered endocrine response is found, these results will be used to identify adjunctive medications or compounds to correct the endocrine response and reduce weight gai
Conditions Studied
Interventions
- DRUG divalproex sodium
Study Locations (1)
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00287053
The ClinicalTrials.gov registry entry for NCT00287053 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which divalproex sodium is the first listed.
NCT00287053 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT00287053 about?
NCT00287053 is a clinical study titled "Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation". The purpose of the proposed study is to identify the mechanisms responsible for the weight gain associated with Depakote treatment, and to identify methods to prevent and treat weight gain in people taking Depakote. Both sides of the energy balance equation will be measured in a sample of healthy le...
What is the current status of trial NCT00287053?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2006-02. Estimated completion is 2006-10.
What conditions does trial NCT00287053 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00287053?
The interventions under investigation include: divalproex sodium (DRUG).
Who is sponsoring clinical trial NCT00287053?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00287053 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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.
-
The Effects of Acute Melatonin Supplementation on Cardiovascular Responses to Sympathetic Activation
RECRUITING · Phase 4
-
Effects of GH and Lirglutide on AgRP
RECRUITING · Phase 4
-
Effects of Caffeine on Reinforcement Learning in Healthy Adults Using PET/MRI
RECRUITING · Phase 4
-
Endothelial Derived Hyperpolarization Factor and Vascular Control
RECRUITING · Phase 4
-
Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
ACTIVE NOT RECRUITING · Phase 4
-
Pharmacokinetics of Transdermal Metronidazole
ACTIVE NOT RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
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.