Characterization of Intestinal Hormone and Glucose Dynamics to Unravel the Antidiabetic Effect of Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in glucose dynamic profile
研究概览
简要总结
This study aims to understand the enteroendocrine physiological changes in superobese patients submitted to two different bariatric procedures (biliopancreatic diversion with duodenal switch versus single anastomosis duodeno-ileal bypass), when perfomed as primary or revisional surgeries (after a sleeve gastrectomy). The main purpose is to establish the metabolic changes obtained with the sleeve gastrectomy and how the revisional procedure maximizes those changes. Additionally, the study will determine whether BPD with DS or SADI-S is superior than the other as first choice for the superobese.
The study will monitor the enteroendocrine function before and after the ingestion of a mixed meal, in pre-operatory and post-surgery timepoints, comparing both primary and revisional surgeries.
详细描述
Abstract Obesity is a chronic disease whose global incidence keeps rising as the twenty first century goes on. Nowadays, the surgical approach constitutes the best treatment option for these patients, making the sleeve gastrectomy and the gastric bypass the more frequently performed bariatric surgeries.
However, the superobese patients (IMC≥ 50kg/m2) present variable weight loss resistance to the previous techniques, showing better results when submitted to disabsorptive procedures, namely the biliopancreatic diversion with duodenal switch, and the more recently created single anastomosis duodeno-ileal bypass. Each constitutes a revisional surgery option after a primary sleeve gastrectomy, reducing surgical and anesthesia risks. This has brought to light that some superobese patients do not need the revisional procedure as they achieve the weight loss target solely by the vertical gastrectomy.
Supported on the investigators' previous work and extensive experience performing both techniques, they now aim to understand the enteroendocrine physiological changes which each procedure accomplishes and compare them in terms of therapeutic efficacy among the superobese. The utmost goals will be to unravel the advantages of BPD-DS and SADI-S as primary or revisional surgeries, the differences between patients that respond well to sleeve gastrectomy alone and those who do not, and, finally, providing further insights on which procedure should be favoured over the other based on the patient characteristics.
Study Overview:
Participants in this study will have been submitted to either BPD-DS or SADI-S, as a primary or as a revisional surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bariatric surgery candidates
- •BMI between 45 and 55 kg/m2
- •Aged between 18 and 65 years at surgery
排除标准
- •Previous abdominal surgery
- •Diabetic patients (Hb A1c > 5,7%) prior to the bariatric procedure
- •Treatment with antidiabetic drugs, except for purposes other than diabetes treatment, prior to the bariatric procedure
结局指标
主要结局
Change in glucose dynamic profile
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months
Glucose will be measured in mmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in GLP-1 dynamic profile
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Glucagon-like peptide-1 (GLP-1) will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in body mass index
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Body mass index (BMI) combines height (in meters) and weight (in kilograms) and is calculated as weight over (height)\^2. Therefore, it will be reported in kg/m\^2. This parameter will be determined at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) at presential visits to the clinic.
Change in glycated haemoglobin
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months
Glycated haemoglobin (HbA1c) will be measured in percentage (%). This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post- surgery) through routine complete biochemical evaluation.
Change in insulin dynamic profile
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Insulin will be measured in mIU/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in glucagon dynamic profile
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Glucagon will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).
Change in GIP dynamic profile
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Glucose-dependent insulinotropic polypeptide (GIP) will be measured in pmol/L. This parameter will be assessed at each study timepoint
次要结局
- Sleep Apnea remission rates(From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery)
- Dyslipidemia remission rates(From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery)
- Metabolic syndrome remission rates(From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery)
- Hypertension remission rates(From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery)
研究者
Marta Guimarães
Principal Investigator
Hospital de Sao Sebastiao