Clinical trial NCT00275834: Zonisamide for Weight Reduction in Obese Adults
Official title: Zonisamide for Weight Reduction in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity treatment
weight loss
antiobesity drugs
zonisamide
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-01-12
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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)

-

Primary outcomes:
measure: Change in Body Weight
timeFrame: 1 year
Secondary outcomes:
measure: Proportions of Patients With 5% Weight Loss
timeFrame: 1 year
measure: Proportions of Patients With 10% Weight Loss
timeFrame: 1 year
measure: Waist Circumference
timeFrame: 1 year
measure: Inflammatory Markers (CRP)
timeFrame: 1 year
measure: Change in Lipids
timeFrame: baseline, 1 year
measure: Quality of Life as Measured by HADS_D
timeFrame: 1 year
measure: Change in Blood Pressure
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Centre
state: North Carolina
Study officials:
affiliation: Duke University
name: Kishore M Gadde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gadde KM, Kopping MF, Wagner HR 2nd, Yonish GM, Allison DB, Bray GA. Zonisamide for weight reduction in obese adults: a 1-year randomized controlled trial. Arch Intern Med. 2012 Nov 12;172(20):1557-64. doi: 10.1001/2013.jamainternmed.99.
citation: Shin JH, Gadde KM, Ostbye T, Bray GA. Weight changes in obese adults 6-months after discontinuation of double-blind zonisamide or placebo treatment. Diabetes Obes Metab. 2014 Aug;16(8):766-8. doi: 10.1111/dom.12275. Epub 2014 Mar 10.