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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00287053
First received: February 2, 2006
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: divalproex sodium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Phase IV Study of the Effects of Divalproex Sodium on Food Intake and Energy Expenditure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in Food Intake. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
    Change in food intake from baseline to week 3.


Secondary Outcome Measures:
  • Change in Posture Allocation and Energy Expenditure. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
  • Change in Body Weight. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
  • Endocrine Response. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]
  • Association of Change With a Behavioral Phenotype. [ Time Frame: February 2006 to September 2006 ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: February 2006
Study Completion Date: October 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Divalproex Sodium
 Drug: divalproex sodium
Divalproex sodium vs. placebo
Placebo Comparator: Placebo Comparator
Placebo Comparator
 Drug: divalproex sodium
Divalproex sodium vs. placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female, age 18 to 54 years
  2. 20 < Body Mass Index (BMI, kg/m2) < 30
  3. Willing to have a blood sample stored for possible future genetic testing

Exclusion Criteria:

  1. 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)
  2. For females, use of any other oral contraceptive other than monophasic oral contraceptives
  3. For females, irregular menstrual cycles
  4. For females, history of partial hysterectomy
  5. For females, nursing
  6. For females, history of polycystic ovarian syndrome
  7. Aspirin use or the refusal to abstain from aspirin use during the study
  8. Current or history of urea cycle disorders
  9. Tobacco users
  10. Use of anti-convulsant medication
  11. Use of barbiturates, such as Phenobarbital
  12. Use of tranquilizers, such as Xanax and Valium
  13. Use of blood thinners, such as Coumadin
  14. Use of anti-depressant medication
  15. Liver disease or impaired liver function
  16. History of pancreatitis
  17. Regular (4 or more days per week) consumption of 3 or more alcoholic beverages a day
  18. Refusal to abstain from alcohol intake during the study
  19. Dietary restraint score > 14 or disinhibition score > 12 on the Eating Inventory [19]
  20. Dislike or allergy to the food used during the food intake tests
  21. Unwilling to wear an IDEEA™ during the study
  22. Unwilling to wear an accelerometer during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287053

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Abbott
Investigators
Principal Investigator: Corby K. Martin, Ph.D. Pennington Biomedical Research Center
  More Information

No publications provided by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Corby Martin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00287053     History of Changes
Other Study ID Numbers: 25031
Study First Received: February 2, 2006
Results First Received: April 21, 2009
Last Updated: September 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
divalproex sodium
valproic acid
food intake
 energy expenditure
posture allocation
None, the population of study is healthy

Additional relevant MeSH terms:
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013