Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

NCT ID: NCT04387058

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-16
• Study Completion Date: 2022-06-16

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.

Detailed Description

Based on our retrospective data, we expect that one-third of cirrhotic patients develop glucose dysregulation after TIPS. A better knowledge of the metabolic disorders related to the TIPS could allow to prevent the deleterious effects of the TIPS on the disease (decrease of the insulin-sensitivity, fat gain ...), by simple interventions on diet or physical activity. We will assess the incidence of diabetes and pre-diabetes, and the influence of TIPS on nutritional status and sarcopenia. Patients will be follow-up 6 months after TIPS. We will explore the hormonal mechanisms that explain these changes.

Conditions

Cirrhosis Portal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

patients with cirrhosis and and portal hypertension

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.

Group Type: OTHER

TIPS

Intervention Type: 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.

Interventions

TIPS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maeva GUILLAUME

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de Toulouse

Toulouse, Haute-garonne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Maeva GUILLAUME

Role: CONTACT

guillaume.m@chu-toulouse.fr

5 61 77 96 49 ext. +33

Facility Contacts

Maeva GUILLAUME

Role: primary

guillaume.m@chu-toulouse.fr

5 61 77 96 49 ext. +33

Other Identifiers

RC31/18/0361

Identifier Type: -

Identifier Source: org_study_id