ChiCTR1900025199已完成Unknown
Changes in HOMA-IR Index Levels After Bariatric Surgery: Comparison of Single Anastomosis Duodenal Switch (SADS) and One Anastomosis Gastric Bypass (OAGB-MGB)
own funding1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2017年5月29日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Improvement of Diabetes
研究概览
简要总结
Bariatric surgery plays a major role in ameliorating metabolic abnormalities of type 2 diabetes (T2DM). The aim of this study was to evaluate the early effects of “Single Anastomosis Duodenal Switch-proximal approach” (SADS-p) and “One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) on the “homeostasis model assessment of insulin resistance” (HOMA-IR) index levels in morbidly obese patients with T2DM.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21 至 66（—）
- 性别
- All
入选标准
- •The study was performed according to the principles of the Helsinki Declaration. Ethics Committee of Ankara Liv Hospital approved the study. In this retrospective, parallel group trial, all patients were evaluated for bariatric surgery by a multidisciplinary team of a surgeon, an endocrinologist, a psychologist, dietitian and an anesthesiologist. Two hundred and sixty morbidly obese patients (Body Mass Index>40kg/m2 or Body Mass Index>35kg/m2 + two co-morbidities) who underwent OAGB-MGB (n=200) and SADS-p (n=60) were included in the study. Patients requiring revisional surgery were excluded from the study. Both surgical techniques were described in detail to the patients. Surgical technique was selected considering the presence of T2DM, body mass index (BMI), eating habits, and requests of the patients. Fasting insulin (FI), fasting blood glucose (FBG), HbA1c, “homeostasis model assessment of insulin resistance” (HOMA-IR index), excess weight loss (EWL), and BMI, body weight were collected before surgery and at 1, 3, 9, 12 months after surgery. HOMA-IR index was calculated from FBG and FI levels.
排除标准
- •explained above.
研究组 & 干预措施
Case series
Nil
结局指标
主要结局
Improvement of Diabetes
次要结局
未报告次要终点
研究者
研究点 (1)
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