Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-03 @ 8:46 PM
Study NCT ID:
NCT04387058
Status:
UNKNOWN
Last Update Posted:
2020-05-13
First Post:
2020-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019168', 'term': 'Portasystemic Shunt, Transjugular Intrahepatic'}], 'ancestors': [{'id': 'D011170', 'term': 'Portasystemic Shunt, Surgical'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 111}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-09', 'studyFirstSubmitDate': '2020-05-09', 'studyFirstSubmitQcDate': '2020-05-09', 'lastUpdatePostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the cumulative incidence', 'timeFrame': '6 months', '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis Portal']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient cirrhosis and portal hypertension justifying a treatment with TIPS\n* written consent.\n\nExclusion Criteria:\n\n* contraindication for TIPS\n* indications of TIPS in emergency or as part of the preparation for a surgical procedure,\n* hepatocellular carcinoma outside Milan criteria or cancer at a palliative stage,\n* a contra-indication to the realization of an OGTT,\n* a hyperglycemic treatment (corticosteroids, somatostatin, etc.),\n* hemoglobin \\<7 g / dl,\n* patients who have had a liver transplant,\n* those for whom the follow-up is considered impossible or the vital prognosis is engaged in the short term,\n* pregnant or lactating women,\n* those unable to receive enlightened information,\n* those participating in interventional research\n* and finally the persons placed under safeguard of justice, tutelage or curatorship.'}, 'identificationModule': {'nctId': 'NCT04387058', 'acronym': 'Gluco-TIPS', 'briefTitle': 'Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'RC31/18/0361'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients with cirrhosis and and portal hypertension', '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.', 'interventionNames': ['Device: TIPS']}], 'interventions': [{'name': 'TIPS', 'type': 'DEVICE', '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.', 'armGroupLabels': ['patients with cirrhosis and and portal hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'state': 'Haute-garonne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maeva GUILLAUME', 'role': 'CONTACT', 'email': 'guillaume.m@chu-toulouse.fr', 'phone': '5 61 77 96 49', 'phoneExt': '+33'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Maeva GUILLAUME', 'role': 'CONTACT', 'email': 'guillaume.m@chu-toulouse.fr', 'phone': '5 61 77 96 49', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Maeva GUILLAUME', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}