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

NCT00287053 | Completed Phase 4 Results

• 1 other identifier: PBRC 25031
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

divalproex sodium; valproic acid; food intake; energy expenditure; posture allocation; None, the population of study is healthy

Outcome Measures

Primary Outcomes (1)

• Change in Food Intake.

  Change in food intake from baseline to week 3.

  February 2006 to September 2006

Secondary Outcomes (4)

• Change in Posture Allocation and Energy Expenditure.

  February 2006 to September 2006

• Change in Body Weight.

  February 2006 to September 2006

• Endocrine Response.

  February 2006 to September 2006

• Association of Change With a Behavioral Phenotype.

  February 2006 to September 2006

Study Arms (2)

Placebo

EXPERIMENTAL

Divalproex Sodium

Drug: divalproex sodium

Placebo Comparator

PLACEBO COMPARATOR

Placebo Comparator

Drug: divalproex sodium

Interventions

divalproex sodium DRUG

Divalproex sodium vs. placebo

Placebo; Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18 to 54 years
• \< 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Abbott: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Martin CK, Han H, Anton SD, Greenway FL, Smith SR. Effect of valproic acid on body weight, food intake, physical activity and hormones: results of a randomized controlled trial. J Psychopharmacol. 2009 Sep;23(7):814-25. doi: 10.1177/0269881108091595. Epub 2008 Jun 26.

  PMID: 18583434 DERIVED

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Limitations and Caveats

This was a short-term study; the long-term effects of this compound on energy balance require further study.

Results Point of Contact

• Title: Corby Martin, Ph.D.; Assistant Professor
• Organization: Pennington Biomedical Reseach Center

martinck@pbrc.edu

225-763-2585

Study Officials

• Corby K. Martin, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: February 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2006
• Last Updated: February 8, 2016
• Results First Posted: June 10, 2009

Record last verified: 2016-01

Locations

US (1)