Fibrosis Reduction in Non Alcoholic Steatohepatitis

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

September 1, 2025

Study Completion Date

September 1, 2026

Conditions
NASH With FibrosisWeight LossBariatric Surgery Candidate
Interventions
PROCEDURE

roux -en-y- gastric bypass

Roux-\&-Y Gastric Bypass (RYGB) involves the use of a surgical stapler to create a small and vertically oriented gastric pouch with a volume of 30 ml. The upper pouch is completely divided by the gastric remnant and is anastomosed to the jejunum, 75 cm distally to the Treitz's ligament, through a narrow gastrojejunal anastomosis in a Roux-en-Y fashion. Bowel continuity is restored by an entero-entero anastomosis, between the excluded biliary limb and the alimentary limb, performed at 100 cm from the gastrojejunostomy.

DIETARY_SUPPLEMENT

intensive life style modification

Weight loss will be induced using a VLCD (800-850 kcal/day; 59% carbohydrate, 13% fat, 26% protein, 2% fiber) with replacement meals for 2 months, followed by structured food reintroduction every 2-8 weeks (about 50% carbohydrate, 35% total fat, and 15% protein), and an ongoing structured program with follow-up visits up to 25% body weight loss

Trial Locations (1)

00188

Mingrone Geltrude, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER