Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

NCT04387058 | Unknown

• 1 other identifier: RC31/18/0361
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Decompensated cirrhosis is associated with sarcopenia. TIPS is an efficient treatment of portal hypertension. Based on our retrospective data, TIPS induces in 30% of cirrhotic patients metabolic disorders associated with diabetes or pre-diabetes. The main objective is to measure the cumulative incidence of diabetes and pre-diabetes 6 months after TIPS insertion.

Conditions

Cirrhosis Portal

Outcome Measures

Primary Outcomes (1)

• the cumulative incidence

  The primary outcome is the cumulative incidence (%) of diabetes and pre-diabetes observed 6 months after TIPS insertion (M6). Diabetes and pre-diabetes will be defined according to World Health Organization (WHO) criteria, based on fasting blood glucose level or 2h after an oral glucose test

  6 months

Study Arms (1)

patients with cirrhosis and and portal hypertension

OTHER

All major patients under 70 years of age with cirrhosis and portal hypertension justifying a treatment with TIPS. These patients must be affiliated to a social security and able to sign a free, informed and written consent.

Device: TIPS

Interventions

TIPS DEVICE

TIPS (Transjugular Intrahepatic Portosystemic Shunt) is an interventional radiology method that creates an anastomosis between the portal venous network and the hepatic venous network.

patients with cirrhosis and and portal hypertension

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient cirrhosis and portal hypertension justifying a treatment with TIPS
• written consent.

You may not qualify if:

• contraindication for TIPS
• indications of TIPS in emergency or as part of the preparation for a surgical procedure,
• hepatocellular carcinoma outside Milan criteria or cancer at a palliative stage,
• a contra-indication to the realization of an OGTT,
• a hyperglycemic treatment (corticosteroids, somatostatin, etc.),
• hemoglobin \<7 g / dl,
• patients who have had a liver transplant,
• those for whom the follow-up is considered impossible or the vital prognosis is engaged in the short term,
• pregnant or lactating women,
• those unable to receive enlightened information,
• those participating in interventional research
• and finally the persons placed under safeguard of justice, tutelage or curatorship.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, Haute-garonne, 31000, France

RECRUITING

MeSH Terms

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Maeva GUILLAUME

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maeva GUILLAUME

CONTACT

5 61 77 96 49; guillaume.m@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 13, 2020
• Study Start: June 16, 2019
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

FR (1)