Liraglutide 6 MG/ML
DrugLiraglutide in incremental dose upto maximum of 1.8 mg per day SC daily
Other names: Calorie restricted diet
NCT Number: NCT04325581
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decompensated liver disease ( child-turcotte pugh score >7)
Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily
Other names: Calorie restricted diet
Normal Saline SC daily
Other names: Calorie restricted diet
Time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Changes in GLP-1 levels during 2hour OGTT
Time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
HOMA-IR calculated from fasting insulin and fasting glucose
Time frame: baseline and 6months after laparoscopic sleeve gastrectomy
Change in pancreatic steatosis would be determined using NUTS ACORN NMR software
Time frame: baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery
The change in body weight
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients
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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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