Zonisamide for Weight Reduction in Obese Adults
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Purpose
The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.
| Condition | Intervention |
|---|---|
|
Obesity |
Drug: Zonisamide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Zonisamide for Weight Reduction in Obese Adults |
- Change in Body Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.
- Proportions of Patients With 5% Weight Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.
- Proportions of Patients With 10% Weight Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.
- Waist Circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.
- Inflammatory Markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Lipids [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Psychological Measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Blood Pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 225 |
| Study Start Date: | January 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Zonisamide 400 mg
|
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo
|
|
Experimental: B
Zonisamide 200 mg
|
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo
|
|
Placebo Comparator: C
matching placebo
|
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo
|
Detailed Description:
This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Age 18-65 years; BMI 30-50
Exclusion Criteria:
Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)
-
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Centre | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Kishore M Gadde, MD | Duke University |
More Information
Publications:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00275834 History of Changes |
| Other Study ID Numbers: | Pro00005514/67352, R01DK067352, 1-RO1-DK067352 |
| Study First Received: | January 10, 2006 |
| Results First Received: | December 10, 2012 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Keywords provided by Duke University:
|
obesity treatment weight loss antiobesity drugs zonisamide |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Body Weight Changes Zonisamide |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Anticonvulsants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013