PROMETEO-HG

Phase 1

• Conditions: Metabolic Associated Fatty Liver Disease with prediabetes.; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2021-000152-19-ES
• Lead Sponsor: Consorcio Centro de Investigación Biomédica en Red, M.P. (CIBER)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-24
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Patients with HGADM according to the clinical criteria of the International Expert Consensus Statement.
2. Age from 18 to 75 years.
3. Men and postmenopausal women.
4. Evidence of significant nonalcoholic fatty liver disease, defined by a proportional attenuation of the intrahepatic signal> 10% observed by magnetic resonance imaging.
5. Overweight or obese with BMI 25-40 kg / m2
6. 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 293
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 97

Exclusion Criteria

1. Patients with a life expectancy that is less than 5 years.
2. History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year.
3. Inability to maintain complete alcohol withdrawal during the study period.
4. Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3).
5. Treatment with drugs potentially associated with fatty liver disease in the previous 3 months (amiodarone, corticosteroids, methotrexate, tetracyclines, tamoxifen, oral contraceptives).
6. 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.
7. Being undergoing chemotherapy or radiotherapy treatment.
8. Other causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis.
9. Active evidence of HBV or HCV infection.
10. Severe heart failure; NYHA functional class III or IV.
11. Type 1 and 2 diabetes.
12. Taking other antidiabetic drugs.
13. 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.
14. 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.
15. Participants in other clinical trials in the 30 days prior to the start of the study.
16. Sexually active men with a woman of childbearing age who plans to become pregnant.
17. Patients with limitation to follow the protocol for any reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified