Effect of Insulin Sensitization on IGF-1 Response to Growth Hormone in SGA Children

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is aimed to determine if Metformin treatment in children born small for gestational age (SGA) who are being treated with Growth Hormone (GH) for short stature improves the response to GH by producing greater concentrations of Insulin-like growth factor -1 (IGF-1) in the blood.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Birmingham Children's Hospital NHS Foundation Trust; Birmingham Women's and Children's NHS Foundation Trust; Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark; Rigshospitalet, Denmark; The National Children's Hospital, Tallaght
• Treatments: Hormones; Insulin; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• SGA children eligible for GH treatment according to European Medicines Agency (EMA) and The National Institute for Health and Care Excellence (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

• Previous participation in a GH trial

• Severe learning difficulties

• Previous or active malignancy

• Benign intracranial hypertension