RANDOMIZED CLINICAL STUDY COMPARING THE EFFECT OF ROUX-en-Y GASTRIC BYPASS AND SLEEVE GASTRECTOMY ON REACTIVE HYPOGLYCEMIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- incidence reactive hypoglycemia
研究概览
简要总结
Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2 obesity associated with complications. Among the bariatric surgical procedures, roux-en-y gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in the United Sates. Sleeve gastrectomy (SG), that was conceived as the first step before performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were super-obese, has recently emerged as a new restrictive bariatric procedure.
Reactive hypoglycemia is a late complication affecting up to 72% of RYGB patients although it seems to occur also after SG, in about 3% of the cases. However, until now no prospective studies have investigated the incidence of hypoglycemia after RYGB nor randomized studies have been undertaken to compare the effect of SG to that of RYGB in terms of incidence of hypoglycemic episodes.
The primary aim of the present study is to conduct a 1-year randomized trial to compare the incidence of hypoglycemia after RYGB or SG.
详细描述
INTRODUCTION Geltrude Mingrone,Simona Panunzi, Andrea De Gaetano, Caterina Guidone, Celestino Pio Lombardi, Marco Raffaelli,Rocco Bellantone Departments of Internal Medicine, Surgery and Biomathematics of the Catholic University of Rome, Italy
The overall prevalence of grade 2 and 3 adult obesity (BMI> 35 kg/m2) derived from the 2009-2010 National Health and Nutrition Examination Survey (NHANES) exceeded 15% and grade 3 obesity (BMI > 40 kg/m2) accounted for 6.3% (1). The dietary approach is modestly satisfactory in the short term and weight regain is practically the rule in the long run as a consequence of the scarce compliance to the diet shown by the obese subjects. In fact, in a recent study (2) where different types of diets were assigned to a population of overweight and obese subjects (BMI from 25 to 40 kg/m2), an average of 6 kg, corresponding to 7% of the initial body weight, was lost in the first 6 months, but the weight was regained after 1 year and at 2 years, only 31-37% of the participants had lost 5% of their initial weight.
Bariatric surgery has long been recognized as an effective treatment for grade 3 or grade 2 obesity associated with complications (3) and, accordingly, the number of bariatric operations in the United States is growing over time from ca. 10,000 in the early 1990s to 103,000 in 2003 (4).
Bariatric surgery allows to type 2 diabetes remission (5,6) while improving several other serious comorbidities (7). Among the bariatric surgical procedures, roux-en-y gastric bypass (RYGB) was shown to account for 41% of all bariatric operations at least in the United Sates (8). Sleeve gastrectomy (SG), that was conceived as the first step before performing a RYGB or a biliopancreatic diversion with duodenal switch in patients who were super-obese (9), has recently emerged as a new restrictive bariatric procedure (10). It was noticed that SG determines a weight loss similar to that achieved after RYGB (11) and larger than that following laparoscopic adjustable gastric banding (12,13).
Reactive hypoglycemia is a late complication of RYGB although it seems to occur also after SG.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible if aged between 25 and 65 years, have a body mass index of 35 (in presence of complications as sleep apnea, severe coxarthritis or gonarthritis, severe hypertension) to 50 kg/m2, and are able to understand and comply with the study process.
排除标准
- •History of type 1 diabetes or secondary diabetes;
- •Previous bariatric surgery;
- •History of medical problems such as mental impairment;
- •Major cardiovascular disease;
- •Major gastrointestinal disease;
- •Major respiratory disease;
- •Hormonal disorders;
- •Infection;
- •History of drug addiction and/or alcohol abuse;
- •Internal malignancy;
- •Pregnancy;
- •Impaired glucose tolerance;
- •Suspected or confirmed poor compliance;
- •Informed consents.
结局指标
主要结局
incidence reactive hypoglycemia
时间窗: up to 12 months
The Primary Endpoint of the study is the incidence reactive hypoglycemia within 1 year after the bariatric surgery.
次要结局
- insulin resistance(0,1,3,6,9, and 12 months)
研究者
Geltrude Mingrone
Associate Professor of Internal Medicine
Catholic University of the Sacred Heart