Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

NCT04325581 | Completed Phase 3

• 1 other identifier: pgi123
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• body weight

  baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery

Study Arms (2)

Post LSG with Liraglutude

EXPERIMENTAL

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

Drug: Liraglutide 6 MG/ML

Post LSG without Liraglutide

PLACEBO COMPARATOR

Normal Saline in equivalent per day subcutaneously once a day

Drug: Placebos

Interventions

Liraglutide 6 MG/ML DRUG

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

Also known as: Calorie restricted diet

Post LSG with Liraglutude

Placebos DRUG

Normal Saline SC daily

Also known as: Calorie restricted diet

Post LSG without Liraglutide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

MeSH Terms

Conditions

Weight Loss

Interventions

Liraglutide; Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Interventional , Placebo Control

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 27, 2020
• Study Start: August 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 27, 2020

Record last verified: 2020-03