Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

Not Applicable

• Conditions: Cirrhosis Portal
• Interventions: Device: TIPS

• Registration Number: NCT04387058
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2019-06-16
• Status Verified: 2020-05
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-09
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with cirrhosis and and portal hypertension	TIPS	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.

Primary Outcome Measures

Name	Time	Method
the cumulative incidence	6 months	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

Trial Locations

Locations (1)

CHU de Toulouse; 🇫🇷 Toulouse, Haute-garonne, France