Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

NCT ID: NCT04325581

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2018-12-31

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.

Conditions

Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Post LSG with Liraglutude

Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day.

Group Type: EXPERIMENTAL

Liraglutide 6 MG/ML

Intervention Type: DRUG

Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily

Post LSG without Liraglutide

Normal Saline in equivalent per day subcutaneously once a day

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Normal Saline SC daily

Interventions

Liraglutide 6 MG/ML

Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily

Intervention Type: DRUG

Placebos

Normal Saline SC daily

Intervention Type: DRUG

Other Intervention Names

Calorie restricted diet; Calorie restricted diet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ashu Rastogi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

pgi123

Identifier Type: -

Identifier Source: org_study_id