Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Liraglutide

Criteria

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