Back to resultsZonisamide for Weight Reduction in Obese Adults
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zonisamide
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity treatment, weight loss, antiobesity drugs, zonisamide
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) -
Sites / Locations
- Duke University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
A
B
C
Arm Description
Zonisamide 400 mg
Zonisamide 200 mg
matching placebo
Outcomes
Primary Outcome Measures
Change in Body Weight
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
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
This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.
Waist Circumference
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)
C reactive Protein (CRP)
Change in Lipids
Quality of Life as Measured by HADS_D
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
Full Information
NCT ID
NCT00275834
First Posted
January 10, 2006
Last Updated
November 15, 2016
Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00275834
Brief Title
Zonisamide for Weight Reduction in Obese Adults
Official Title
Zonisamide for Weight Reduction in Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity treatment, weight loss, antiobesity drugs, zonisamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Zonisamide 400 mg
Arm Title
B
Arm Type
Experimental
Arm Description
Zonisamide 200 mg
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Intervention Description
zonisamide 400 mg, 200 mg, or placebo
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportions of Patients With 5% Weight Loss
Description
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.
Time Frame
1 year
Title
Proportions of Patients With 10% Weight Loss
Description
This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.
Time Frame
1 year
Title
Waist Circumference
Description
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.
Time Frame
1 year
Title
Inflammatory Markers (CRP)
Description
C reactive Protein (CRP)
Time Frame
1 year
Title
Change in Lipids
Time Frame
baseline, 1 year
Title
Quality of Life as Measured by HADS_D
Description
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.
Time Frame
1 year
Title
Change in Blood Pressure
Time Frame
Baseline, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore M Gadde, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Centre
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23147455
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.
Results Reference
background
PubMed Identifier
25123600
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.
Results Reference
derived
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Zonisamide for Weight Reduction in Obese Adults
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