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Control strategies and pharmacogenetic study for the personalized treatment of fatty liver associated with metabolic dysfunction in patients with prediabetes.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516561-37-01
Acronym
PROMETEO-HG
Enrollment
390
Registered
2024-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Associated Fatty Liver Disease with prediabetes.

Brief summary

Significant decrease in the amount of intrahepatic fat (> 20%) in the absence of liver fibrosis progression.

Detailed description

Study of insulin resistance and adipose tissue dysfunction, Search for non-invasive markers of efficacy of the proposed treatments among circulating metabolites (metabolomic and lipidomic methods)., Study of the intestinal microbiota., Pharmacogenetic study: influence of genetic variations on the degree of therapeutic response to drugs., Study of bioimpedanciometry., Collection of adverse events potentially related to the medication and its administration.

Interventions

DRUGPioglitazone Holsten 15 mg tabletter
DRUGMetformin Hydrochloride 500mg Tablets

Sponsors

Consorcio Centro De Investigacion Biomedica En Red
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Study of insulin resistance and adipose tissue dysfunction, Search for non-invasive markers of efficacy of the proposed treatments among circulating metabolites (metabolomic and lipidomic methods)., Study of the intestinal microbiota., Pharmacogenetic study: influence of genetic variations on the degree of therapeutic response to drugs., Study of bioimpedanciometry., Collection of adverse events potentially related to the medication and its administration.

Primary

MeasureTime frame
Significant decrease in the amount of intrahepatic fat (> 20%) in the absence of liver fibrosis progression.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026