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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04387058
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Portal Device: TIPS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
Actual Study Start Date : June 16, 2019
Estimated Primary Completion Date : June 16, 2022
Estimated Study Completion Date : June 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. the cumulative incidence [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387058


Contacts
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Contact: Maeva GUILLAUME 5 61 77 96 49 ext +33 guillaume.m@chu-toulouse.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, Haute-garonne, France, 31000
Contact: Maeva GUILLAUME    5 61 77 96 49 ext +33    guillaume.m@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Maeva GUILLAUME University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04387058    
Other Study ID Numbers: RC31/18/0361
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases