Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Drug: Liraglutide 6 MG/ML; Drug: Placebos

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Post LSG with Liraglutude; Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day.	Drug: Liraglutide 6 MG/ML; Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily; Other Names: Calorie restricted diet
Placebo Comparator: Post LSG without Liraglutide; Normal Saline in equivalent per day subcutaneously once a day	Drug: Placebos; Normal Saline SC daily; Other Names: Calorie restricted diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incretin change	Changes in GLP-1 levels during 2hour OGTT	baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Changes in indices of insulin resistance	HOMA-IR calculated from fasting insulin and fasting glucose	baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Change in pancreatic steatosis	Change in pancreatic steatosis would be determined using NUTS ACORN NMR software	baseline and 6months after laparoscopic sleeve gastrectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	The change in body weight	baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: pgi123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No