BridgeMD
PROMETEO-HG
EU CTIS ID: 2024-516561-37-01
What this study is testing
To determine which of the three models of therapeutic intervention induces a greater sustained regression of fatty liver associated with long-term metabolic disease (18 months) measured by non-invasive techniques (MRI) in patients with Metabolic Associated Fatty Liver Disease and prediabetes.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with HGADM according to the clinical criteria of the International Expert Consensus Statement.
- Age from 18 to 75 years.
- Men and postmenopausal women.
- Evidence of significant nonalcoholic fatty liver disease, defined by a proportional attenuation of the intrahepatic signal> 10% observed by magnetic resonance imaging.
- Overweight or obese with BMI 25-40 kg / m2
- Presence of Prediabetes according to the ADA criteria (fasting blood glucose 100-125 mg / dl or HbA1c 5.7% -6.4% or blood glucose 140-199 mg / dl at 2 hours after SOG).
You likely can't join if
- Patients with a life expectancy that is less than 5 years.
- Severe heart failure; NYHA functional class III or IV.
- Type 1 and 2 diabetes.
- Taking other antidiabetic drugs.
- Chronic diseases not related to metabolic disease: severe psychiatric, chronic kidney failure (GFR <45 ml / min), chronic respiratory failure, chronic processes necessary for treatment that can modify glucose metabolism.
- Severe cardiovascular, renal, endocrine, gastrointestinal, or psychiatric comorbidity that, in the opinion of the investigator, may make adherence to treatment or interpretation of results difficult.
See the full eligibility criteria
- Patients with HGADM according to the clinical criteria of the International Expert Consensus Statement.
- Age from 18 to 75 years.
- Men and postmenopausal women.
- Evidence of significant nonalcoholic fatty liver disease, defined by a proportional attenuation of the intrahepatic signal> 10% observed by magnetic resonance imaging.
- Overweight or obese with BMI 25-40 kg / m2
- Presence of Prediabetes according to the ADA criteria (fasting blood glucose 100-125 mg / dl or HbA1c 5.7% -6.4% or blood glucose 140-199 mg / dl at 2 hours after SOG).
- Patients with a life expectancy that is less than 5 years.
- Severe heart failure; NYHA functional class III or IV.
- Type 1 and 2 diabetes.
- Taking other antidiabetic drugs.
- Chronic diseases not related to metabolic disease: severe psychiatric, chronic kidney failure (GFR <45 ml / min), chronic respiratory failure, chronic processes necessary for treatment that can modify glucose metabolism.
- Severe cardiovascular, renal, endocrine, gastrointestinal, or psychiatric comorbidity that, in the opinion of the investigator, may make adherence to treatment or interpretation of results difficult.
- Participants in other clinical trials in the 30 days prior to the start of the study.
- Sexually active men with a woman of childbearing age who plans to become pregnant.
- Patients with limitation to follow the protocol for any reason.
- History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year.
- Inability to maintain complete alcohol withdrawal during the study period.
- Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3).
- Treatment with drugs potentially associated with fatty liver disease in the previous 3 months (amiodarone, corticosteroids, methotrexate, tetracyclines, tamoxifen, oral contraceptives).
- History of hepatocarcinoma or malignancy in the 5 years prior to inclusion in the study, except cervical carcinoma in situ and basal cell carcinoma or cutaneous basal cell carcinoma.
- Being undergoing chemotherapy or radiotherapy treatment.
- Other causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis.
- Active evidence of HBV or HCV infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.