NCT04820036 - A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 6, 2021

Primary Completion Date

December 24, 2024

Study Completion Date

December 31, 2025

Conditions

Non-alcoholic Steatohepatitis (NASH)Endoscopic Sleeve GastroplastyNon-alcoholic Fatty Liver Disease (NAFLD)Endoscopic UltrasoundLiver FunctionObesityLiver Fibroses

Interventions

DIAGNOSTIC_TEST

Insulin Resistance

Insulin resistance: Fasting glucose and insulin will also be measured to calculate Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), as a surrogate of IR

BEHAVIORAL

Quality of Life Assessment

Quality of life will be assessed using the Chronic Liver Disease Questionnaire.

DIAGNOSTIC_TEST

Liver Function Test

EUS-guided liver biopsy and portal pressure gradient measurement

DIAGNOSTIC_TEST

Radiologic features of NASH

Controlled attenuation parameter (CAP) and liver stiffness scores assessed by transient elastography (TE)

DIAGNOSTIC_TEST

Serologic features of NASH

Laboratory value assessment of alanine aminotransferase (ALT), liver chemistries, platelet counts, albumin and calculated NAFLD Fibrosis Score (NFS).

Trial Locations (1)

02115

Brigham and Women's Hospital, Boston