Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy

In brief

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 gain. Genomic studies will also be possible, since gene sequencing and gene expression can be analyzed from archived buffy coat samples.

Key facts

Study ID: NCT00287053
Run by: Pennington Biomedical Research Center
People needed: 57
Starts: 2006-02-01
Expected to finish: 2006-10-01
Last updated by the study team: 2016-02-08

Who can join

Age: 18 and older, up to 54. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy male or female, age 18 to 54 years
20 < Body Mass Index (BMI, kg/m2) < 30
Willing to have a blood sample stored for possible future genetic testing

You may not qualify if…

For females, pregnant or unwilling to use an effective form of contraception while on this study (hormonal methods like birth control pills, implants or shots; barrier methods like condoms or diaphragms with foam; surgical sterilization; or abstinence)
For females, use of any other oral contraceptive other than monophasic oral contraceptives
For females, irregular menstrual cycles
For females, history of partial hysterectomy
For females, nursing
For females, history of polycystic ovarian syndrome
Aspirin use or the refusal to abstain from aspirin use during the study
Current or history of urea cycle disorders
Tobacco users
Use of anti-convulsant medication
Use of barbiturates, such as Phenobarbital
Use of tranquilizers, such as Xanax and Valium
Use of blood thinners, such as Coumadin
Use of anti-depressant medication
Liver disease or impaired liver function
History of pancreatitis
Regular (4 or more days per week) consumption of 3 or more alcoholic beverages a day
Refusal to abstain from alcohol intake during the study
Dietary restraint score > 14 or disinhibition score > 12 on the Eating Inventory [19]
Dislike or allergy to the food used during the food intake tests
Unwilling to wear an IDEEA™ during the study
Unwilling to wear an accelerometer during the study

Where it is running

Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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