Zonisamide for Weight Reduction in Obese Adults - Tabular View

Tracking Information

First Received Date ^ICMJE

January 10, 2006

Last Updated Date

July 22, 2009

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in body weight

Change History

Complete list of historical versions of study NCT00275834 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportions of patients with 5% and 10% weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Glycaemic indices [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ]

Original Secondary Outcome Measures ^ICMJE

Proportions of patients with 5% and 10% weight loss
Waist circumference
Glycaemic indices
Inflammatory markers
Lipids
Quality of life
Psychological measures
Blood pressure

Descriptive Information

Brief Title ^ICMJE

Zonisamide for Weight Reduction in Obese Adults

Official Title ^ICMJE

Zonisamide for Weight Reduction in Obese Adults

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: Zonisamide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

November 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00275834

Responsible Party

Kishore Gadde, Duke University Medical Center

Study ID Numbers ^ICMJE

67352, 1-RO1-DK067352

Study Sponsor ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kishore M Gadde, MD

Duke University

Information Provided By

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP