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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post LSG with Liraglutude | Experimental | Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day. |
|
| Post LSG without Liraglutide | Placebo Comparator | Normal Saline in equivalent per day subcutaneously once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide 6 MG/ML | Drug | Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incretin change | Changes in GLP-1 levels during 2hour OGTT | baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy |
| Changes in indices of insulin resistance | HOMA-IR calculated from fasting insulin and fasting glucose | baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy |
| Change in pancreatic steatosis | Change in pancreatic steatosis would be determined using NUTS ACORN NMR software | baseline and 6months after laparoscopic sleeve gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| body weight | The change in body weight | baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Decompensated liver disease ( child-turcotte pugh score >7)
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Interventional , Placebo Control
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| Placebos | Drug | Normal Saline SC daily |
|
|
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |