Zonisamide for Weight Reduction in Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years; BMI 30-50
排除标准
- •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)
研究组 & 干预措施
A
Zonisamide 400 mg
干预措施: Zonisamide (Drug)
B
Zonisamide 200 mg
干预措施: Zonisamide (Drug)
C
matching placebo
干预措施: Zonisamide (Drug)
结局指标
主要结局
Change in Body Weight
时间窗: 1 year
The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.
次要结局
- Proportions of Patients With 5% Weight Loss(1 year)
- Proportions of Patients With 10% Weight Loss(1 year)
- Waist Circumference(1 year)
- Inflammatory Markers (CRP)(1 year)
- Change in Lipids(baseline, 1 year)
- Quality of Life as Measured by HADS_D(1 year)
- Change in Blood Pressure(Baseline, 1 year)