Effects of the Surgical Removal of Visceral Fat Tissue (Omentectomy) on Insulin Sensitivity in Grade III Obese Volunteers Subjected to Bariatric Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.
研究概览
简要总结
The intraabdominal fat is associated with insulin resistance, a condition that is in the basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear whether it is the origin of it or a surrogate marker only. We intend to compare the effects of bariatric surgery with versus without omentectomy in morbidly obese people intended to go through bariatric surgery, accessing insulin sensitivity by metabolic tests.
If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy) might lead to improvement of insulin action, as seen in animal studies and in one study with morbidly obese human volunteers.
详细描述
In order to verify a potential additional benefit of omentectomy combined to Roux-en-Y silastic ring gastric bypass, insulin sensitivity will be studied by the gold-standard test, euglycemic-hyperinsulinemic clamp, since early postoperative follow-up (before significant weight variation), compared to a control group of bariatric surgery (same technique) alone. The variables will be analyzed in the post surgical evolution for correlation to metabolic changes: adiposity-related hormones and cytokines; lipid profile and other cardiovascular risk factors; molecular expression of biopsied subcutaneous adipocytes in vitro; anthropometrics; ultrasonography of abdominal subcutaneous and intra-abdominal fat depots and carotid intima-media thickness (preclinical atherosclerosis evaluation).
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 21 and 50 years.
- •Female sex.
- •BMI between 40 and 50kg/m
- •Metabolic syndrome (NCEP/ATP III criteria).
排除标准
- •Weight variation >5% within 3 months prior to preoperative tests.
- •Use of antidiabetic medications within 3 months prior to preoperative tests.
- •HbA1c >8%.
- •Use of systemic corticosteroids for longer than 1 week within 3 months prior to preoperative tests.
- •Hepatic cirrhosis, renal failure or any clinical condition (other than obesity) recognized as impairing insulin sensitivity.
- •Present Smoking.
结局指标
主要结局
Increase of insulin sensitivity as measured by euglycemic-hyperinsulinemic clamp.
时间窗: one month, six months and one year.
次要结局
- increase of insulin secretion as measured by intravenous glucose tolerance test(one month, six months, one year)
- regression of carotid intima-media thickness(one month, six months, one year)
- Improvement of the insulin cell signalling in the subcutaneous adipose tissue.(one month, six months)
- increase of adipocytokines linked to greater insulin sensitivity and decrease of others linked to insulin resistance(one month, six months, one year)
研究者
Marcelo Miranda de Oliveira Lima, MD, PhD
Marcelo Miranda de Oliveira Lima, MD, PhD
University of Campinas, Brazil