search
Back to results

Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

Primary Purpose

Weight Loss

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Liraglutide 6 MG/ML
Placebos
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Post LSG with Liraglutude

    Post LSG without Liraglutide

    Arm Description

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

    Normal Saline in equivalent per day subcutaneously once a day

    Outcomes

    Primary Outcome Measures

    Incretin change
    Changes in GLP-1 levels during 2hour OGTT
    Changes in indices of insulin resistance
    HOMA-IR calculated from fasting insulin and fasting glucose
    Change in pancreatic steatosis
    Change in pancreatic steatosis would be determined using NUTS ACORN NMR software

    Secondary Outcome Measures

    body weight
    The change in body weight

    Full Information

    First Posted
    March 20, 2020
    Last Updated
    March 26, 2020
    Sponsor
    Postgraduate Institute of Medical Education and Research
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04325581
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Postgraduate Institute of Medical Education and Research

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Interventional , Placebo Control
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Post LSG with Liraglutude
    Arm Type
    Experimental
    Arm Description
    Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day.
    Arm Title
    Post LSG without Liraglutide
    Arm Type
    Placebo Comparator
    Arm Description
    Normal Saline in equivalent per day subcutaneously once a day
    Intervention Type
    Drug
    Intervention Name(s)
    Liraglutide 6 MG/ML
    Other Intervention Name(s)
    Calorie restricted diet
    Intervention Description
    Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Other Intervention Name(s)
    Calorie restricted diet
    Intervention Description
    Normal Saline SC daily
    Primary Outcome Measure Information:
    Title
    Incretin change
    Description
    Changes in GLP-1 levels during 2hour OGTT
    Time Frame
    baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
    Title
    Changes in indices of insulin resistance
    Description
    HOMA-IR calculated from fasting insulin and fasting glucose
    Time Frame
    baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
    Title
    Change in pancreatic steatosis
    Description
    Change in pancreatic steatosis would be determined using NUTS ACORN NMR software
    Time Frame
    baseline and 6months after laparoscopic sleeve gastrectomy
    Secondary Outcome Measure Information:
    Title
    body weight
    Description
    The change in body weight
    Time Frame
    baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients

    We'll reach out to this number within 24 hrs