A Pilot Study of Metabolic Effects of Omentectomy in Obese Patients With Type 2 Diabetes Mellitus Treated With Laparoscopic Adjustable Gastric Banding (LAGB)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
研究概览
简要总结
PROTOCOL SUMMARY
Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation We hypothesize that removal of omental fat increases insulin sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.
Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.
We hypothesize that the genetic samples will help us to identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity and help us to design future obesity genetic studies.
Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for weight loss at New York University Medical Center will be invited to participate in this study. Subjects will be randomly assigned, by using a computer-generated randomization scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).
详细描述
Inclusion Criteria:
- Patients who consented to undergo LAGB for weight loss and consent to participate in this study
- BMI ≥35 kg/m2
- Confirmed T2DM treated with oral agents and/or only diet therapy
- Age 18-64 years
Exclusion Criteria:
- Insulin therapy
- Weight change (>2% body weight) within 4 weeks before surgery
- Patients with T2DM for more than 10 years
Research Design- Pilot Study Event Week (approximate) Medical Screening (in conjunction with routine pre-op visit) -4 OGTT & randomization -2 Preliminary genetic testing for the future study (blood sample) -2 Surgery with or without omentectomy 0 Preliminary genetic testing for the future study (fat sample) 0 Weight stabilization visit (in conjunction with routine post-op visit) 2 Weight stabilization visit (in conjunction with routine post-op visit) 4 OGTT 6
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who consented to undergo LAGB for weight loss and consent to participate in this study
- •BMI ≥35 kg/m2
- •Confirmed T2DM treated with oral agents and/or only diet therapy
- •Age 18-64 years
排除标准
- •Insulin therapy
- •Weight change (>2% body weight) within 4 weeks before surgery
- •Patients with T2DM for more than 10 years
结局指标
主要结局
1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation
时间窗: 6 week post op
次要结局
- Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.(6 week post op)