Prospective intervention trial with adjuvant metformin in girls and boys with classic congenital adrenal hyperplasia.

Prospective intervention trial with adjuvant metformin in girls and boys with classic CAH (METFOR CAH). - METFOR CAH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002395-40-BE

Enrollment

Registered

2013-11-19

Start date

2014-03-24

Completion date

Unknown

Last updated

2018-03-05

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

Conditions

congenital adrenal hyperplasia (CAH) MedDRA version: 16.1 Level: LLT Classification code 10010323 Term: Congenital adrenal hyperplasia System Organ Class: 100000004850

Interventions

Trade Name: Metformine Sandoz 850 mg filmomhulde tabletten Product Name: Metformine Pharmaceutical Form: Film-coated tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE Other descriptive name: METFORM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: Girls and boys with classic CAH due to 21-hydroxylase deficiency (“salt-wasting” and “simple virilizing” forms), reaching the age of 8 years (girls) and 9 years (boys) in the period 2014 – 2018. Controls: Girls and boys with classic CAH due to 21-hydroxylase deficiency (“salt-wasting” and “simple virilizing” forms), who are between 8 (girls) or 9 (boys) and 16 years at start of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no 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: Affected children on glucocorticoid treatment other than HC. Mental retardation (IQ<70), syndromic patients.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): improvement of metabolic and cardiovascular risk parameters: Body composition, lipid profile, insulin resistance, adiponectin, hs-CRP, carotid artery intima media thickness (caIMT).;Timepoint(s) of evaluation of this end point: After 2 years of intake of 2 x 425 mg/day of Metformin and 3 years of 2x 850 mg/day of Metformin.;Main Objective: To determine whether 2+3 years of adjuvant MF therapy during puberty (girls: from 8 years onwards, boys: from 9 years onwards) improves any of the following metabolic and cardiovascular risk parameters: Body composition, lipid profile, insulin resistance, adiponectin, hs-CRP, carotid artery intima media thickness (caIMT);Secondary Objective: To determine whether 2+3 years of adjuvant MF therapy can increase final height in boys and girls with CAH To determine whether adjuvant MF treatment can result in a dose reduction of HC, allowing similar metabolic control of disease To determine whether eventual beneficial effects of MF are maintained after cessation of treatment To determine whether eventual beneficial effects of MF correlate with severity of disease, as predicted by described genotype-phenotype correlations To longitudinally study QoL in children and adolescents with CAH To collect longitudinal data on therapeutic compliance with regard to HC treatment in children and adolescents with CAH	—

Measure

Time frame

Primary end point(s): improvement of metabolic and cardiovascular risk parameters: Body composition, lipid profile, insulin resistance, adiponectin, hs-CRP, carotid artery intima media thickness (caIMT).;Timepoint(s) of evaluation of this end point: After 2 years of intake of 2 x 425 mg/day of Metformin and 3 years of 2x 850 mg/day of Metformin.;Main Objective: To determine whether 2+3 years of adjuvant MF therapy during puberty (girls: from 8 years onwards, boys: from 9 years onwards) improves any of the following metabolic and cardiovascular risk parameters: Body composition, lipid profile, insulin resistance, adiponectin, hs-CRP, carotid artery intima media thickness (caIMT);Secondary Objective: To determine whether 2+3 years of adjuvant MF therapy can increase final height in boys and girls with CAH To determine whether adjuvant MF treatment can result in a dose reduction of HC, allowing similar metabolic control of disease To determine whether eventual beneficial effects of MF are maintained after cessation of treatment To determine whether eventual beneficial effects of MF correlate with severity of disease, as predicted by described genotype-phenotype correlations To longitudinally study QoL in children and adolescents with CAH To collect longitudinal data on therapeutic compliance with regard to HC treatment in children and adolescents with CAH

—

Secondary

Measure	Time frame
Secondary end point(s): Increase of final height in boys and girls with CAH; dose reduction of HC, increase of QoL. ;Timepoint(s) of evaluation of this end point: After 2 years of intake of 2 x 425 mg/day of Metformin and 3 years of 2x 850 mg/day of Metformin.	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

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