Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

Cirrhosis Portal Clinical Trial

— Gluco-TIPS  

Official title:

Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04387058
• Other study ID #: RC31/18/0361
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: June 16, 2022

Study information

• Verified date: May 2020
• Source: University Hospital, Toulouse
• Contact: Maeva GUILLAUME
• Phone: 5 61 77 96 49
• Email: guillaume.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis Portal
• Metabolic Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse	Haute-garonne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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