Status:
COMPLETED
Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Weight Loss
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 intrapancreat...
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04325581
Start Date
August 1 2016
End Date
December 31 2018
Last Update
March 27 2020
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