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Taking people in SpainPhase 3

Compares 3 treatment approaches for fatty liver disease in adults with prediabetes

Compares 3 treatment approaches for fatty liver in adults with prediabetes.

Key facts

Who runs it
Consorcio Centro De Investigacion Biomedica En Red
Where
Córdoba, Málaga, Sevilla, and Tarragona, SpainSee the 5 sites
Registry title
PROMETEO-HG
Status
Recruiting
Phase
Phase 3
People taking part
390 people, planned
Started
19 Dec 2024
Planned end
24 Feb 2026
Type of study
Interventional
Record updated
19 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fatty liver linked to metabolic problems who also have prediabetes and are overweight or obese.

Age
18 to 75 years
Sex
Men and postmenopausal women
Disease stage
Fatty liver disease linked to metabolic problems (MRI shows more than 10% fat signal in the liver). Prediabetes by ADA criteria (fasting blood glucose 100-125 mg/dl (5.6–6.9 mmol/L), or HbA1c 5.7% (39 mmol/mol)-6.4% (46 mmol/mol), or blood glucose 140-199 mg/dl (7.8–11 mmol/L) 2 hours after a glucose drink). BMI 25-40 kg/m2.
Earlier treatment
Cannot have taken drugs linked to fatty liver in the previous 3 months (amiodarone, corticosteroids, methotrexate, tetracyclines, tamoxifen, oral contraceptives). Cannot have taken other antidiabetic drugs. Cannot have had other trials in the previous 30 days.

Main reasons for not taking part

  • Type 1 or type 2 diabetes
  • Decompensated liver cirrhosis or altered liver function
  • Alcohol use above 30 g/day in men or 20 g/day in women for 3 months in the last year
  • Severe heart failure (NYHA class III or IV) or life expectancy under 5 years
  • Other causes of fatty liver, or active hepatitis B or C infection

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Taking other antidiabetic drugs
  • Participants in other clinical trials in the 30 days prior to the start of the study
  • 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
  • Severe heart failure; NYHA functional class III or IV
  • Type 1 and 2 diabetes
  • 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
  • History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year
  • Other causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis
  • Active evidence of HBV or HCV infection
  • 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
  • Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3)
  • Sexually active men with a woman of childbearing age who plans to become pregnant
  • Patients with a life expectancy that is less than 5 years
  • Patients with limitation to follow the protocol for any reason
  • Inability to maintain complete alcohol withdrawal during the study period

Where in Spain

  • Hospital Universitario Reina SofiaCórdoba, SpainTaking people
  • Hospital Universitario Regional de MálagaMálaga, SpainTaking people
  • Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
  • University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
  • Hospital Universitari Joan XXIII de TarragonaTarragona, SpainTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Control strategies and pharmacogenetic study for the personalized treatment of fatty liver associated with metabolic dysfunction in patients with prediabetes.
Plain-language title
Compares 3 treatment approaches for fatty liver disease in adults with prediabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
19 December 2024