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

NCT02931591 | Unknown DMC

• 1 other identifier: SGA Metformin Study
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Small for Gestational Age

Keywords

Small for gestational age; insulin sensitivity; IGF-1 response; growth hormone treatment

Outcome Measures

Primary Outcomes (1)

• IGF-1 response

  Area under the curve of IGF-1 standard deviation scores over 6 months

  6 months

Secondary Outcomes (3)

• Height velocity

  6 months and 1 year

• Insulin sensitivity

  6 months and 1 year

• Insulin secretion

  6 months

Study Arms (2)

GH+Metformin

ACTIVE COMPARATOR

The children will be given both Growth Hormone and Metformin for 6 months

Drug: Metformin; Drug: Growth Hormone

GH+Placebo

PLACEBO COMPARATOR

Children will be given both GH and Placebo for 6 months

Drug: Growth Hormone; Drug: Placebo

Interventions

Metformin DRUG

Metformin is administered as an oral solution

GH+Metformin

Growth Hormone DRUG

Growth Hormone- no specific band

GH+Metformin; GH+Placebo

Placebo DRUG

GH+Placebo

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known or suspected allergy to GH
• Previous participation in a GH trial
• Severe learning difficulties
• Previous or active malignancy
• Benign intracranial hypertension

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Rigshospitalet, Denmark: collaborator
• Birmingham Women's and Children's NHS Foundation Trust: collaborator
• The National Children's Hospital, Tallaght: collaborator

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin; Growth Hormone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

David B Dunger, MD

CONTACT

+441223 762944; dbd25@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Paediatrics

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: October 13, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: June 1, 2020
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share