Cirrhosis Portal
Conditions
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.
Interventions
DEVICETIPS
TIPS (Transjugular Intrahepatic Portosystemic Shunt) is an interventional radiology method that creates an anastomosis between the portal venous network and the hepatic venous network.
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
Primary ContactMaeva GUILLAUME
Outcome results
None listed