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

Primary Purpose

Cirrhosis Portal

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TIPS
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis Portal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patients with cirrhosis and and portal hypertension

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2020
Last Updated
May 9, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04387058
Brief Title
Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
Acronym
Gluco-TIPS
Official Title
Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2019 (Actual)
Primary Completion Date
June 16, 2022 (Anticipated)
Study Completion Date
June 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis Portal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with cirrhosis and and portal hypertension
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
TIPS
Intervention Description
TIPS (Transjugular Intrahepatic Portosystemic Shunt) is an interventional radiology method that creates an anastomosis between the portal venous network and the hepatic venous network.
Primary Outcome Measure Information:
Title
the cumulative incidence
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maeva GUILLAUME
Phone
5 61 77 96 49
Ext
+33
Email
guillaume.m@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maeva GUILLAUME
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
State/Province
Haute-garonne
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maeva GUILLAUME
Phone
5 61 77 96 49
Ext
+33
Email
guillaume.m@chu-toulouse.fr

12. IPD Sharing Statement

Learn more about this trial

Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients

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