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临床试验/NCT00212160
NCT00212160已完成不适用

The Role of the Omentum in the Treatment of Morbid Obesity

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2005年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
change in insulin sensitivity

研究概览

简要总结

The purpose of this research is to determine some of the reasons that blood sugar and insulin levels improve after bariatric surgery but before weight loss begins, as well as why people respond differently to weight loss surgery. It will also examine whether removing the fat around the stomach and large intestine (the omentum) will improve weight loss. Finally, it will see why there are differences between Whites and African Americans who have weight loss surgery.

详细描述

The purpose of this research is to tease out the mechanisms related to changes in insulin sensitivity, metabolism, hormones, and body composition following bariatric surgery. Because preliminary data indicate differing responses to this surgery, both Caucasian and African American adults, scheduled for RYGB, are being recruited to participate. It is believed that the omentum contributes to hepatic insulin resistance, both because of the increased delivery of NEFAs via the portal vein, and the increased production of cytokines. Because of this, it is postulated that removing the omentum as part of bariatric surgery will speed up the reversal of insulin resistance and diminish racial differences in response to the surgery.

Data are derived from tissue and blood samples obtained operatively (from individuals having bariatric surgery and other abdominal operations), as well as during hyperinsulinemic-euglycemic clamps, from indirect calorimetry, DEXA, Health-related Quality of Life surveys, and 24-hour urine samples. There were 66 participants randomized to omentectomy/no omentectomy. A post hoc data power analysis determined that this number of subjects is sufficient for data analysis.

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 (Participant)

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
是

入选标准

  • •BMI > 40
  • •BMI > 35 with co-morbidities
  • •normal creatinine/liver labs
  • •insurance approval for RYGB or resources to self-pay
  • •proximity to Nashville, TN

排除标准

  • •use of anticoagulants, steroids, therapeutic niacin
  • •previous bariatric surgery

研究组 & 干预措施

RYGB with omentectomy

Experimental

Subjects undergoing RYGB will be randomized to also have the greater omentum removed at the time of surgery.

干预措施: omentectomy (Procedure)

RYGB without omentectomy

No Intervention

Subjects undergoing RYGB will be randomized to NOT have the greater omentum removed at the time of surgery.

Normal body weight

No Intervention

Healthy normal weight subjects studied via hyperinsulinemic-euglycemic clamp to obtain reference values for insulin sensitivity and other metabolic parameters.

Tissue samples

No Intervention

Tissue samples (omental fat, subcutaneous fat, muscle,and blood)are obtained from subjects of varying weights during abdominal surgery in order to compare various parameters, including inflammation, oxidative stress, and gene expression, among tissues across weight classes.

结局指标

主要结局

change in insulin sensitivity

时间窗: 5 year

次要结局

  • Weight loss(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naji Abumrad

Chairman, Department of Surgery

Vanderbilt University Medical Center

研究点 (1)

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