Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase

Completed

Phase 3

Conditions

Weight Loss

Treatments

Drug: Liraglutide 6 MG/ML

Drug: Placebos

Study type

Interventional

Funder types

Other

Identifiers

NCT04325581

pgi123

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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