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Completed

NCT Number: NCT04325581

Laparocopic Sleeve Gastrectomy With or Without Liraglutide 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liraglutide 6 MG/ML

Drug

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

Other names: Calorie restricted diet

Placebos

Drug

Normal Saline SC daily

Other names: Calorie restricted diet

Primary outcomes

  1. Incretin change

    Time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy

    Changes in GLP-1 levels during 2hour OGTT

  2. Changes in indices of insulin resistance

    Time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy

    HOMA-IR calculated from fasting insulin and fasting glucose

  3. Change in pancreatic steatosis

    Time frame: baseline and 6months after laparoscopic sleeve gastrectomy

    Change in pancreatic steatosis would be determined using NUTS ACORN NMR software

Secondary outcomes

  1. body weight

    Time frame: baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery

    The change in body weight

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2020
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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