Dubbel blind gerandomiseerde studie waar metformine versus placebo toegediend worden in de behandeling van NASH bij patiënten die omwille van obesitas bariatrische chirurgie ondergaan.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000596-17-BE

Enrollment

Registered

2005-07-15

Start date

2005-08-04

Completion date

Unknown

Last updated

2014-10-27

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

Conditions

Obesitas

Interventions

Trade Name: Glucophage Product Name: Glucophage Pharmaceutical Form: Coated tablet INN or Proposed INN: Metforminehydrochloride CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Histologische diagnose van NASH/NAFLD * Insulineresistent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Diabetes mellitus type I * Endocriene oorzaak van obesitas (vb Cushing, ...) * Patiënten met andere oorzaken van leverlijden (HBV, HCV, PBC, ...) * Verhoogd lactaat * Nierfalen (serum creatinine hoger dan 1,5 mg/dL) * Congestief hartfalen

Design outcomes

Primary

Measure	Time frame
Main Objective: Amelioration of histology after 1 year treatment with metformine in obese patients and NASH undergoing bariatric surgery.;Secondary Objective: * Amelioration of ALT levels after 1 year of treatment with metformine * Amelioration of insulin resistance as measured by HOMA after 1 year of treatment with metformine * Lowering of TNFalfa levels after 1 year of treatment with metformine;Primary end point(s): Amelioration of histology after 1 year treatment with metformine in obese patients and NASH undergoing bariatric surgery.	—

Measure

Time frame

Main Objective: Amelioration of histology after 1 year treatment with metformine in obese patients and NASH undergoing bariatric surgery.;Secondary Objective: * Amelioration of ALT levels after 1 year of treatment with metformine * Amelioration of insulin resistance as measured by HOMA after 1 year of treatment with metformine * Lowering of TNFalfa levels after 1 year of treatment with metformine;Primary end point(s): Amelioration of histology after 1 year treatment with metformine in obese patients and NASH undergoing bariatric surgery.

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026