Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

Phase 3

Completed

• Conditions: Weight Loss
• Interventions: Drug: Liraglutide 6 MG/ML; Drug: Placebos

• Registration Number: NCT04325581
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Study First Posted: 2020-03-27
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post LSG with Liraglutude	Liraglutide 6 MG/ML	Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day.
Post LSG without Liraglutide	Placebos	Normal Saline in equivalent per day subcutaneously once a day

Primary Outcome Measures

Name	Time	Method
Incretin change	baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy	Changes in GLP-1 levels during 2hour OGTT
Change in pancreatic steatosis	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	baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy	HOMA-IR calculated from fasting insulin and fasting glucose

Secondary Outcome Measures

Name	Time	Method
body weight	baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery	The change in body weight