Treatment with Metformin and growth hormone in children with a low birth weight

Effect of insulin sensitization on insulin like growth factor-1 responses to growth hormone treatment in children born small for gestational age - SGA Metformin study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000584-85-DK

Enrollment

Registered

2018-03-21

Start date

2018-11-21

Completion date

Unknown

Last updated

2018-12-04

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

Conditions

Growth disorder in children born small for gestational age MedDRA version: 20.1 Level: LLT Classification code 10040600 Term: Short stature System Organ Class: 100000004848

Interventions

Trade Name: Metformin Product Name: Metformin Pharmaceutical Form: Oral solution INN or Proposed INN: METFORMIN CAS Number: 657-24-9 Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: • SGA children eligible for GH treatment according to EMA and NICE criteria • Gestational age at birth >28 weeks • Age 4-9 years in girls and 4-10 years in boys • Prepubertal at start of treatment • Naïve to GH therapy Are the trial subjects under 18? yes Number of subjects for this age range: 24 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Inclusion Criteria: • SGA children eligible for GH treatment according to EMA and NICE criteria • Gestational age at birth >28 weeks • Age 4-9 years in girls and 4-10 years in boys • Prepubertal at start of treatment • Naïve to GH therapy Exclusion Criteria • Known or suspected allergy to GH • Known or suspected hypersensitivity or allergy to Metformin • Previous participation in a GH trial • Severe learning difficulties • Previous or active malignancy • Benign intracranial hypertension • Diabetes • Growth failure due to chronic diseases, syndromes, or chromosomal anomalies • Cardiac, pulmonary, hepatic or renal diseases associated with significant decompensation • Psychological problems likely to lead to significant non-compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effects of insulin sensitization using Metformin on the circulating levels of IGF-1 over 6 months in SGA children started on GH treatment;Secondary Objective: 1. To determine the effects of the intervention over 6 months on height velocity, insulin sensitivity, insulin secretion and glucose tolerance 2. To determine the effects of Metformin treatment on IGF-1 levels, height velocity, insulin sensitivity and body composition after 6 months of discontinuation of Metformin. ;Primary end point(s): Circulating levels of IGF-I over 6 months in SGA children started on Metformin/placebo and Growth hormone;Timepoint(s) of evaluation of this end point: After 6 and 12 months of growth hormone treatment	—

Measure

Time frame

Main Objective: To determine the effects of insulin sensitization using Metformin on the circulating levels of IGF-1 over 6 months in SGA children started on GH treatment;Secondary Objective: 1. To determine the effects of the intervention over 6 months on height velocity, insulin sensitivity, insulin secretion and glucose tolerance 2. To determine the effects of Metformin treatment on IGF-1 levels, height velocity, insulin sensitivity and body composition after 6 months of discontinuation of Metformin. ;Primary end point(s): Circulating levels of IGF-I over 6 months in SGA children started on Metformin/placebo and Growth hormone;Timepoint(s) of evaluation of this end point: After 6 and 12 months of growth hormone treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Effects of the intervention over 6 months on height velocity, insulin sensitivity, insulin secretion and glucose tolerance;Timepoint(s) of evaluation of this end point: After 6 and 12 months of treatment	—

Countries

Denmark

Contacts

Public ContactRikke Beck Jensen

Rigshospitalet

rikke.beck.jensen@regionh.dk+4535456859

Outcome results

None listed

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