Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Incretin change
研究概览
简要总结
Investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese patients in a placebo controlled design.
详细描述
Various studies have shown that bariatric surgery is associated with significant durable weight loss with associated improvement in obesity related comorbidities and quality of life. The degree of effect on obesity related comorbidities depends on the bariatric surgery approach, typically classified as restrictive and/or malabsorptive effect. Data from International Federation for the Surgery of Obesity and Metabolic Diseases states that most common surgical procedures being performed are Roux-en-Y gastric bypass (45%), sleeve gastrectomy(37%), adjustable gastric banding(10%) and biliopancreatic division with or without duodenal switch(2.5%)5. . LSG is technically a simpler procedure compared to RYGB with lesser operative and long term nutritional complications. The mechanism for weight loss in laparoscopic sleeve gastrectomy is gastric restriction and possible changes in gut hormones resulting from higher level of GLP-1, and lower levels of ghrelin, as a consequence of resection of gastric fundus.
Therefore,investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese participants in a placebo controlled design.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects diagnosed with obesity who have elected to undergo bariatric surgery
- •Body mass index greater than 27.5kg/mt2
- •Ability and willingness to co-operate with follow up.
排除标准
- •Decompensated liver disease ( child-turcotte pugh score >7)
- •Impaired renal function, defined as eGFR< 45 ml/min/m2
- •Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class III and IV)
- •Recurrent major hypoglycemic episodes
- •Use of drugs like systemic corticosteroids, thiazolidinediones, DPPIV inhibitors
- •Pregnancy or lactation
- •History of pancreatitis or pancreatic cancer
- •History of medullary thyroid cancer
- •Family history of medullary thyroid cancer
- •Contraindications to liraglutide or any of its excipients
- •Hypersensitivity to liraglutide or similar drugs
- •Patients currently using GLP-1 analogs
- •Suspected or known abuse of alcohol
- •Presence of secondary cause of obesity.
- •Presence of an eating disorder or other psychiatric disorder.
- •Prior gastric surgery.
- •Unfit for surgery due to severe cardiac, pulmonary diseases or due to any reason.
- •Contraindications to MRI scanning
研究组 & 干预措施
Post LSG with Liraglutude
Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day.
干预措施: Liraglutide 6 MG/ML (Drug)
Post LSG without Liraglutide
Normal Saline in equivalent per day subcutaneously once a day
干预措施: Placebos (Drug)
结局指标
主要结局
Incretin change
时间窗: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Changes in GLP-1 levels during 2hour OGTT
Change in pancreatic steatosis
时间窗: baseline and 6months after laparoscopic sleeve gastrectomy
Change in pancreatic steatosis would be determined using NUTS ACORN NMR software
Changes in indices of insulin resistance
时间窗: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
HOMA-IR calculated from fasting insulin and fasting glucose
次要结局
- body weight(baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery)
研究者
Ashu Rastogi
Assistant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh