Endoscopic Sleeve Gastroplasty for fatty liver disease and metabolic syndrome

Not Applicable

• Conditions: Non Alcoholic fatty Liver Disease; on Alcoholic fatty Liver Disease; Metabolic and Endocrine - Diabetes; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Obesity; Metabolic syndrome; Diet and Nutrition - Obesity

• Registration Number: ACTRN12619000066189
• Lead Sponsor: ew Zealand Liver Transplant Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-17
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Liver biopsy with NAFLD/NASH (NAS score greater than or equal to 4), (or historic biopsy within 6-months)
AND
2. BMI 30- 45Kg/m2. AND at least one additional metabolic risk factor: (HT, Type II diabetes or dyslipidaemia).
AND
3. Age 20- 65

Exclusion Criteria

Patients with cirrhosis of the liver and/or portal hypertension,
Antiplatelet therapy (excluding low dose aspirin),
Severe cardiac or respiratory disease, Previous gastric surgery, Hiatus hernia >3cm
Inflammatory bowel disease,
Pregnancy, or breast feeding.
No other liver disease (excluded viral hepatitis, AIH, HFe, alpha-1 AT deficiency),
Medications known to cause steatohepatitis.
Alcohol consumption: >21U/ week male, >14U/week female
Unable to follow dietary guidelines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iver biopsy assessment of change in Non Alcoholic Fatty Liver Disease histologic score (NAFLD Activity Score; NAS).[1 year post ESG Liver Biopsy]

Secondary Outcome Measures

Name	Time	Method
Change in insulin resistance with blood test, 1 year post ESG[1 year post ESG];Weight loss (total body weight change measured on electronic scales in Kg) at 1 year post ESG[1 year post ESG];Change in blood pressure with bench top spygmomanometer 1 year post ESG[1 year post ESG];Change in liver fat on fibroscan at 1 year post ESG[1 year post ESG, fibroscan assessment of liver fat with computerised attenuation parameter (CAP)];Change in lipid profile at 1 year post ESG with blood test.[1 year post ESG blood test]