Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients (Gluco-TIPS)

Toulouse University Hospital

Status: Unknown

Conditions: Cirrhosis Portal

Treatments: Device: TIPS

Study type: Interventional

Funder types: Other

Identifiers

NCT04387058

RC31/18/0361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

patients with cirrhosis and and portal hypertension

Other group

Description:

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.

Treatment:

Device: TIPS