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
About this trial
This is an interventional treatment trial for Weight Loss
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
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
NCT ID
NCT04325581
First Posted
March 20, 2020
Last Updated
March 26, 2020
Sponsor
Postgraduate Institute of Medical Education and Research
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
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