NCT00872378Unknown2 期
A Pilot Study of the Effects of BYETTA® (Exenatide) on Weight Loss in Morbidly Obese Non Diabetic Patients Following Adjustable Gastric Banding
Advanced Specialty Care2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan.
研究概览
简要总结
The purpose of this study is to describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide or placebo injections.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years,
- •Have a body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbidities (1991 NIH Guidelines for Bariatric Surgery),
- •For women of childbearing age, must have a negative pregnancy test at screening, and agree to use barrier contraceptives for the duration of the study, AND
- •Are able to understand and comply with the study process, and give informed consent.
排除标准
- •A diagnosis of type 1 diabetes mellitus,
- •A diagnosis of type 2 diabetes mellitus (A diagnosis of T2DM will be a previous fasting plasma glucose greater than or equal to 126 mg/dL, or a random plasma glucose greater than 200 mg/dL),
- •Have experienced hypersensitivity reaction or a worsening of glycemic control on Byetta® (exenatide),
- •Patients with end stage renal disease or severe renal impairment,
- •Patients with severe gastrointestinal disease, including gastroparesis,
- •Liver function tests 2.5 standard deviations above normal values,
- •Contraindication for bariatric surgery,
- •Treatment with exenatide (Byetta) in the last three months,
- •Currently using or have used within three months before this trial: sibutramine, orlistat, or phentermine(patients must also agree to not use these medications for the duration of the study),
- •Treatment with any investigational drug in the last 30 days,
- •Active malignancy, liver of kidney failure, symptomatic coronary heart disease, or severe psychiatric disease,
- •History of malignancy other than basal cell skin carcinoma, OR
- •In the opinion of the investigator, patient is abusing alcohol and/or drugs.
研究组 & 干预措施
Exenatide
Active Comparator
Laparoscopic adjustable gastric banding group: twice daily exenatide therapy plus a standard diet and exercise program
干预措施: Exenatide (Drug)
Placebo
Placebo Comparator
Laparoscopic adjustable gastric banding group: twice daily placebo therapy plus a standard diet and exercise program
干预措施: Placebo (Drug)
结局指标
主要结局
To describe change in body weight in non-diabetic morbidly obese patients after laparoscopic adjustable gastric banding (LAGB) with twice daily exenatide plus lifestyle modification plan or placebo plus lifestyle modification plan.
时间窗: 52 weeks
次要结局
- Body Mass Index (BMI)(52 Weeks)
- Waist circumference(52 Weeks)
- Changes in: 2 hour Oral Glucose Tolerance Test; Lipid panel; Comprehensive metabolic panel; Glycosylated hemoglobin A1c(52 Weeks)
- Carotid intima media thickness(CIMT)(52 Weeks)
研究者
研究点 (2)
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