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
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in insulin dynamic profile
研究概览
简要总结
This study will determine how two variants of gastric bypass induce changes in dynamic endocrine response in the fasting and post-prandial state, both before and at different time points after the surgical interventions.
This study will monitor the endocrine dynamics after different anatomical modifications produced by Roux-en-Y gastric bypass procedures in diabetic participants and normoglycemic participants, to gain insights into the mechanisms beyond the metabolic improvement after the two surgical variants through participants re-evaluation at different time points.
详细描述
Abstract
Obesity prevalence is a major risk factor for the onset of type 2 diabetes. Diabetic patients are frequently overweight or obese and diabetes complications are the main cause of obesity-related morbimortality, demanding proper and effective clinical management.
Bariatric surgery, originally conceived for obesity treatment, has proven not only to be the most effective weight loss intervention but also for comorbidity management, with a strong impact on type 2 diabetes. As the antidiabetic effects of bariatric surgery largely exceed the metabolic improvement predicted by the caloric restriction and weight loss, which are mostly driven by the enteroendocrine response, this challenges the academic and medical communities with the need to learn how to leverage the enteroendocrine system to achieve glucose homeostasis.
Supported on the investigators' previous work focusing on gastro-intestinal hormones and glucose metabolism after bariatric surgery, the investigators now aim to monitor the intestinal hormone after different anatomical modifications produced by Roux-en-Y gastric bypass procedures in diabetic participants and normoglycemic individuals. The utmost goal will be to unravel the endocrine mechanisms beyond the metabolic improvement observed after the surgical manipulations, towards the identification of novel targets for hormone based treatments in an individualised clinical approach.
Study Overview: Participants in this study will be submitted to either short or long BPL RYGB surgery. Participants visits will be scheduled before surgery and after surgery at 3, 6 and 12 months for detailed participants assessment that will include anthropometric and biochemical evaluation and the performance of a MMTT with plasma sampling for hormonal profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •BMI between 35 and 45 kg/m2 with indication for bariatric surgery
- •Aged between 18 and 65 years at surgery
排除标准
- •Unwillingness, inability or intolerance to complete the MMTT (ingest 200 mL in 15 minutes or less)
结局指标
主要结局
Change in insulin dynamic profile
时间窗: Time Frame: 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 glycated haemoglobin
时间窗: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
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 GLP-1 dynamic profile
时间窗: Time Frame: 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 GIP dynamic profile
时间窗: Time Frame: 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 (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 glucose dynamic profile
时间窗: Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
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 glucagon dynamic profile
时间窗: Time Frame: 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).
次要结局
未报告次要终点
研究者
Marta Guimarães
SURIDIAB-1 Principal investigator
Hospital de Sao Sebastiao