New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvement or reversal of type 2 diabetes mellitus
研究概览
简要总结
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
详细描述
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.
This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity grade I (BMI 30-34,9)
- •Weight variance less than 5% in the last 3 months.
- •Previous diagnosis of diabetes type
- •Insulin requirement, alone or along with oral agents
- •Capacity to understand the procedures of the study.
- •To agree voluntarily to participate of the study, signing an informed consent.
排除标准
- •Positive Anti-GAD antibodies
- •Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
- •History of hepatic disease like cirrhosis or chronic active hepatitis.
- •Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
- •Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
- •Recent history of neoplasia (< 5 years).
- •Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
结局指标
主要结局
Improvement or reversal of type 2 diabetes mellitus
时间窗: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.
次要结局
- Changes in body weight and fat distribution after intervention(1 month, 2 months, 3 months, 6 months and 1 year)
- Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test(6 months and 1 year)
- Improvement of insulin sensitivity as measured by insulin tolerance test(1 month, 3 months, 6 months and 1 year)
- Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines(one month, 2 months, 3 months, 6 months and 1 year)
- Regression of carotid intima-media thickness(1 month, 3 months, 6 months and 1 year)
- Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography(1 year and 2 years)
- Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography(1 year and 2 years)
- Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection(6 months, 1 year and 2 years)
研究者
Bruno Geloneze
Prof Dr Bruno Geloneze, MD, PhD
University of Campinas, Brazil