Facilitated Release of Endogenous Enterokines: An Ambulatory Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Weight change between groups
研究概览
简要总结
The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.
详细描述
Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who undergo this procedure and is also highly effective therapy for obesity. However, currently <1% of medically-eligible patients undergo this or other bariatric operations due to cost and safety concerns. The approach is based on data suggesting that the benefit of gastric bypass is largely due to anatomical rearrangement of the intestine which leads to accelerated delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of multiple neural, hormonal and enterokine responses that are associated with appetite suppression and improved glucose control. In this pilot proposal the question under investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can promote weight loss and glucose control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes on oral antidiabetic medication
- •BMI greater than or equal to 30kg/m2
- •A1C less than 9%
排除标准
- •Use of any of the following medications: dipeptide-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide) or medication that could alter glucose tolerance (e.g. steroids)
- •Contraindication to tube (e.g. Prior upper gastrointestinal bleed, or history of easy bleeding, altered foregut anatomy due to obstruction or surgery)
- •Known cardiovascular disease other than controlled hypertension.
- •Pregnancy or unwilling to take contraception
- •Active esophagitis
- •Known hiatal hernia
- •Active gastric ulcer and/or duodenal ulcers,
- •Previous restrictive surgery of the gastrointestinal tract
- •Crohn's disease
- •Active cancer
- •History of gastrointestinal hemorrhage
- •Known upper gastrointestinal lesions with potential to bleed
- •Use of NSAIDs or anticoagulants
- •Psychiatric disorders other than mild depression
- •Likely inability to adhere to study protocol including alcohol or drug dependent patients
- •Type I diabetes,
- •Liver, kidney or multi-organ dysfunction.
- •Known eating disorders
- •Inability to attend scheduled or unanticipated study visits
- •Known prior abdominal problems or operations that could lead to adhesions or strictures and that could prevent the spontaneous passage of a 10 French jejunal tube if it were to dislodge distally.
结局指标
主要结局
Weight change between groups
时间窗: Day 0 to Day 14
Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group
次要结局
- Caloric intake within and between groups(Day 0 to Day 14)
- Change in systolic and diastolic blood pressure(Day 0 to Day 14)
- Change in heart rate(Day 0 to Day 14)
- Weight change within group(Day 0 to Day 14)
- Change in waist and hip measurements(Day 0 to Day 14)
- Changes in gut hormone levels(Day 0 to Day 14)
研究者
Elizabeth Beale
Assistant Professor
University of Southern California