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

NCT02931591 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-10-14

No results posted yet for this study

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

Interventions

DRUG

Metformin

Metformin is administered as an oral solution

DRUG

Growth Hormone

Growth Hormone- no specific band

DRUG

Placebo

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Birmingham Women's and Children's NHS Foundation Trust

    collaborator OTHER

  • The National Children's Hospital, Tallaght

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-30
Completion
2020-06-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931591 on ClinicalTrials.gov