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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00287053
First Posted: February 6, 2006
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center
  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: Triple (Participant, 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:


Further study details as provided by Corby K. Martin, Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in Food Intake. [ Time Frame: February 2006 to September 2006 ]
    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 ]
  • Change in Body Weight. [ Time Frame: February 2006 to September 2006 ]
  • Endocrine Response. [ Time Frame: February 2006 to September 2006 ]
  • Association of Change With a Behavioral Phenotype. [ Time Frame: February 2006 to September 2006 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corby K. Martin, Associate Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00287053     History of Changes
Other Study ID Numbers: PBRC 25031
First Submitted: February 2, 2006
First Posted: February 6, 2006
Results First Submitted: April 21, 2009
Results First Posted: June 10, 2009
Last Update Posted: February 8, 2016
Last Verified: January 2016

Keywords provided by Corby K. Martin, 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
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