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The study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intragastric Balloon | Intragastric Balloon will be placed for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intragstric Ballooning | Procedure | Intragstric Ballooning will be put. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight from baseline | 3 months | |
| Change in weight reduction from baseline | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in development of liver related complications | 3 Months | |
| Change in development of liver related complications | 6 Months | |
| Improvement of insulin resistance in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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NASH (Non Alcoholic SteatoHepatitis) cirrhosis.
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| Name | Affiliation | Role |
|---|---|---|
| Shiv Kumar Sarin, DM | Institute of Liver & Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35763235 | Derived | Vijayaraghavan R, Sarin SK, Bharadwaj A, Anand L, Maiwall R, Choudhury A, Benjamin J, Kanal U, Jamwal KD. Intragastric Balloon in Obese Compensated Nonalcoholic Steatohepatitis Cirrhosis Patients Is Safe and Achieves Significant Weight Reduction at 6-Months. Dig Dis Sci. 2023 Mar;68(3):1035-1041. doi: 10.1007/s10620-022-07596-4. Epub 2022 Jun 28. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| 3 Months |
| Improvement of insulin resistance in both groups. | 6 Months |
| Decreased usage of medications for diabetes mellitus in both groups. | 3 Months |
| Decreased usage of medications for diabetes mellitus in both groups. | 6 Months |
| Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. | 3 Months |
| Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. | 6 Months |
| Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). | 3 Months |
| Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). | 6 Months |
| Improvement in liver parameters such as serum albumin in both groups. | 3 Months |
| Improvement in liver parameters such as serum albumin in both groups. | 6 Months |
| Improvement liver parameters such as INR in both groups | 3 Months |
| Improvement in liver parameters such as INR in both groups. | 6 Months |
| Improvement in liver parameters such as bilirubin in both groups | 3 Months |
| Improvement in liver parameters such as bilirubin in both groups. | 6 Months |
| Disappearance of esophageal varices in both groups. | 3 Months |
| Disappearance of esophageal varices in both groups. | 6 Months |
| Improvement in LSM (liver stiffness on fibroscan) in both groups | 3 Months |
| Improvement in LSM (liver stiffness on fibroscan) in both groups. | 6 Months |
| Improvement in CAP (Controlled Attenuation Index) in both groups. | 3 Months |
| Improvement in CAP (Controlled Attenuation Index) in both groups. | 6 Months |
| Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. | 3 Months |
| Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. | 6 Months |
| Improvement in liver histology post completion of study in both groups. | 6 Months |
| Change in hormonal levels such as Adiponectin level in both groups.. | 3 Months |
| Change in hormonal levels such as Adiponectin level in both groups. | 6 months |
| Change in hormonal levels such as leptin level in both groups. | 3 Months |
| Change in hormonal levels such as Ghrelin level in both groups.. | 3 Months |
| Change in hormonal levels such as Ghrelin level in both groups.. | 6 Months |
| Change in hormonal levels such as Endothelin level in both groups.. | 3 Month |
| Change in hormonal levels such as Endothelin level in both groups.. | 6 Month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |