Effects on Non-Alcoholic Steato-Hepatitis (NASH) liver disease, obesity-associated metabolicdisturbances, weight loss, safety and quality of life in adults with NASH and obesity undergoing endoscopic sleeve gastroplasty.

Not Applicable

• Conditions: on-alcoholic fatty liver disease; obesity; Non-alcoholic fatty liver disease; Metabolic and Endocrine - Metabolic disorders; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12618001888257
• Lead Sponsor: Dr Damian Harding (Chief researcher)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-20
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

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

Inclusion Criteria

Obesity (body mass index) of greater than or equal to 35kg/m2, and up to 45kg/m2.
Diagnosis of non-alcoholic steato-hepatitis (NASH) based on liver biopsy.

Exclusion Criteria

-Cirrhosis
-Significant alcohol consumption (>20g/day females, >30g/day males)
-Other causes of liver disease (untreated viral hepatitis, auto-immune hepatitis)
-Other significant medical morbidity associated with a poor long term prognosis or high pre-procedural risk. (This includes a history of previous unprovoked deep vein thrombosis or pulmonary embolism.)
-Anti-coagulation
-Use of medications that may affect the natural history of NAFLD/ NASH (obeticholic acid, pioglitazone, incretin mimetics, such as liraglutide; SGLT-2 inhibitors).
-History of previous gastric or oesophageal surgery, gastric ulcer, hiatus hernia >5cm.
-Pregnancy. (Where applicable) female subjects should avoid pregnancy pre-operatively and for 12 to 18 months post-operatively.
-Current active psychiatric illness, substance abuse or dependence.
-Presence of chronic, un-evaluated abdominal pain symptoms.
-Unwilling to consent to study requirements for monitoring and follow up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASH liver disease as assessed by improvement in liver histology (defined as resolution of steato-hepatitis without worsening of fibrosis, using the NAFLD Activity Score and Kleiner fibrosis classification of liver fibrosis), and by serum liver function tests.[Blood tests at weeks 24 and 48 post-ESG procedure. Liver biopsy at week 48 post-ESG procedure.<br>];Composite outcome of change in metabolic status (insulin resistance or glycaemic control, urinary albuminuria, lipid profiles) and blood pressure as assessed by HOMA-IR, HbA1c, fasting serum glucose and insulin, total cholesterol, HDL, LDL, triglycerides, urinary albumin: creatinine ratio. Systolic and diastolic blood pressure (mmHg) recorded using a digital blood pressure monitor..[Week 48 post-ESG intervention.];Composite outcome of change in weight/ improvement of obesity as assessed by digital scale, calculation of body mass index.[Measurement of weight and calculation of body mass index at weeks 12, 24, 36 and 48 post-ESG procedure.<br>]

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life as assessed by SF36 score.<br>[Week 48 following ESG procedure.];Incidence of adverse clinical events arising following ESG procedure, such as venous thromboembolism, re-intervention or unplanned hospital admissions. This will be assessed at week 4 post-ESG with a modified version of the World Health Organisation RF1 patient safety Adverse Event Detection Questionnaire, and at weeks 8, 12, 24, 36 and 48 using a study-specific adverse event screening tool. <br><br>assessed using ICH/ FDA classification of adverse events in clinical trials (Clinical safety data management: Definitions and standards for expedited reporting.” United States Food and Drug Administration; 1995 ).[Week 0 collection of ESG procedure data, questionnaires at weeks 4, 8, 12, 24, 36, and week 48 clinical assessment.]