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

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.

Study Overview

• Status: Unknown
• Conditions: Cirrhosis Portal
• Intervention / Treatment: Device: TIPS

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 Type: Interventional
• Enrollment (Anticipated): 111
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maeva GUILLAUME; Phone Number: +33 5 61 77 96 49; Email: guillaume.m@chu-toulouse.fr

Study Locations

• France
  • Haute-garonne
    • Toulouse, Haute-garonne, France, 31000
      • Recruiting
      • CHU De Toulouse
      • Contact: Maeva GUILLAUME; Phone Number: +33 5 61 77 96 49; Email: guillaume.m@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Maeva GUILLAUME, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2019
• Primary Completion (Anticipated): June 16, 2022
• Study Completion (Anticipated): June 16, 2022

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: RC31/18/0361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No