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

Phase 1

• Conditions: Growth disorder in children born small for gestational age; MedDRA version: 20.1Level: LLTClassification code 10040600Term: Short statureSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2018-000584-85-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-21
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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.<br>;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 Outcome Measures

Name	Time	Method
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