Cirrhosis PortalGluco-TIPSNCT04387058
Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
A study testing TIPS in people with Cirrhosis Portal, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis Portal
- What is being tested?
- TIPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2019to 16 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient cirrhosis and portal hypertension justifying a treatment with TIPS
- written consent.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Toulouse
Toulouse, Haute-garonne, 31000
Maeva GUILLAUME, 5 61 77 96 49 ext. +33, guillaume.m@chu-toulouse.fr
About this study
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.
Read the 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.
- Conditions
- Cirrhosis Portal
- Being tested
- TIPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSDevice
TIPS (Transjugular Intrahepatic Portosystemic Shunt) is an interventional radiology method that creates an anastomosis between the portal venous network and the hepatic venous network.
| Study group | Role | What they receive |
|---|---|---|
| patients with cirrhosis and and portal hypertension | Other | 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. Receives: Device: TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start16 Jun 2019
- Primary completion16 Jun 2022 (estimated)
- Study completion16 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis PortalStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maeva GUILLAUME, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387058
- Sponsor's protocol ID
- RC31/18/0361
- Acronym
- Gluco-TIPS
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 13 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Diabetes and Metabolic Disorders After TIPS in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT04387058
- Acronym / sponsor ID
- Gluco-TIPS / RC31/18/0361
- Conditions
- Cirrhosis Portal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 16 Jun 2022 (estimated)
- Study completion
- 16 Jun 2022 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with cirrhosis and and portal hypertension | Other | Device: TIPSAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient cirrhosis and portal hypertension justifying a treatment with TIPS
- written consent.
Key exclusion criteria (12 listed)
- 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.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPSTIPS (Transjugular Intrahepatic Portosystemic Shunt) is an interventional radiology method that creates an anastomosis between the portal venous network and the hepatic venous network. | Device | patients with cirrhosis and and portal hypertension |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
Related trials for Cirrhosis Portal
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maeva GUILLAUME principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS in people with Cirrhosis Portal, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maeva GUILLAUME (5 61 77 96 49 ext. +33, guillaume.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cumulative incidence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.