Clinical trial NCT04325581: Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients
Official title: Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2020-03-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional , Placebo Control
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incretin change
timeFrame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
measure: Changes in indices of insulin resistance
timeFrame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
measure: Change in pancreatic steatosis
timeFrame: baseline and 6months after laparoscopic sleeve gastrectomy
Secondary outcomes:
measure: body weight
timeFrame: baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery
Other outcomes:
Locations:
Study officials:
References: