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Zonisamide for Weight Reduction in Obese Adults

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00275834
First received: January 10, 2006
Last updated: November 15, 2016
Last verified: November 2016
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zonisamide for Weight Reduction in Obese Adults

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: 1 year ]
    The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.


Secondary Outcome Measures:
  • Proportions of Patients With 5% Weight Loss [ Time Frame: 1 year ]
    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 ]
    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 ]
    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 (CRP) [ Time Frame: 1 year ]
    C reactive Protein (CRP)

  • Change in Lipids [ Time Frame: baseline, 1 year ]
  • Quality of Life as Measured by HADS_D [ Time Frame: 1 year ]
    Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.

  • Change in Blood Pressure [ Time Frame: Baseline, 1 year ]

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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275834

Locations
United States, North Carolina
Duke University Medical Centre
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kishore M Gadde, MD Duke University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00275834     History of Changes
Other Study ID Numbers: Pro00005514
R01DK067352 ( U.S. NIH Grant/Contract )
1R01DK067352 ( U.S. NIH Grant/Contract )
Study First Received: January 10, 2006
Results First Received: December 10, 2012
Last Updated: November 15, 2016

Keywords provided by Duke University:
obesity treatment
weight loss
antiobesity drugs
zonisamide

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Zonisamide
Anticonvulsants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 20, 2017