Small for Gestational AgeNCT02931591
Effect of Insulin Sensitization on IGF-1 Response to Growth Hormone in SGA Children
A study testing Metformin and Growth Hormone in people with Small for Gestational Age, run by Cambridge University Hospitals NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Small for Gestational Age
- What is being tested?
- Metformin and Growth Hormone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Known or suspected allergy to GH
- Previous participation in a GH trial
- Severe learning difficulties
- Previous or active malignancy
- Benign intracranial hypertension
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Insulin Sensitization on Insulin Like Growth Factor-1 Responses to Growth Hormone Treatment in Children Born Small for Gestational Age
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.
Read the detailed description
Growth hormone treatment (GH) is recommended in children born small for gestational age (SGA) who fail to catch-up. SGA is a heterogeneous condition as reflected in the varied response to GH treatment. Variable generation and resistance to Insulin-like growth factor-1 (IGF-1), the most important circulating mediator of GH action may underpin this heterogeneity. An association between the variants in the genes related to lower insulin sensitivity and reduced IGF-1 and growth response to GH therapy in SGA children have been reported recently. The hypothesis of this study is that insulin sensitivity may be causally linked to the response to GH therapy, and adjuvant therapy with an insulin sensitizer may improve IGF-1 generation, decrease IGF-I resistance and optimise growth response.
To explore this hypothesis, this study aims to determine the effects of insulin sensitization using Metformin as an adjuvant to a fixed dose GH therapy for 6 months in short SGA children. The patients will be short SGA children between age 4 -10 years and identified from three paediatric endocrine units in Denmark, Ireland and the United Kingdom. In this mechanistic study 24 subjects starting GH treatment will be randomised in a 1:1 ratio to adjunctive Metformin or placebo for 6 months and followed-up for another 6months. The participants will receive GH treatment for the entire duration of the study (12 months) and will undergo an oral glucose tolerance test and dual-energy x-ray absorptiometry scan to determine glucose metabolism and body fat mass respectively at baseline and 6 months, and will have 3 monthly measurements of height, weight and skinfold thickness. The primary outcome will be the area under the curve of IGF-1 levels measured at 0, 1, 3 and 6 months. Secondary outcomes will include changes in insulin sensitivity, height, body fat mass and safety measures at 6 and 12 months.
- Conditions
- Small for Gestational Age
- Being tested
- Metformin, Growth Hormone, Placebo
- Keywords
- Small for gestational age, insulin sensitivity, IGF-1 response, growth hormone treatment
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin is administered as an oral solution
Growth HormoneDrug
Growth Hormone- no specific band
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GH+Metformin | Active comparator | The children will be given both Growth Hormone and Metformin for 6 months Receives: Drug: Metformin; Drug: Growth Hormone |
| GH+Placebo | Placebo comparator | Children will be given both GH and Placebo for 6 months Receives: Drug: Growth Hormone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 response
Area under the curve of IGF-1 standard deviation scores over 6 months
Measured: 6 months
Secondary outcomes (3)
Height velocity
Height increments
Measured: 6 months and 1 year
Insulin sensitivity
Measured by homeostasis model assessment model
Measured: 6 months and 1 year
Insulin secretion
Measured by oral glucose tolerance test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Birmingham Women's and Children's NHS Foundation Trust, The National Children's Hospital, Tallaght
- Responsible party
- Principal investigator, David B Dunger, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931591
- Sponsor's protocol ID
- SGA Metformin Study
- Status last verified
- Oct 2016
- First submitted
- 14 Sep 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insulin Sensitization on Insulin Like Growth Factor-1 Responses to Growth Hormone Treatment in Children Born Small for Gestational Age
- ClinicalTrials.gov ID
- NCT02931591
- Acronym / sponsor ID
- SGA Metformin Study
- Conditions
- Small for Gestational Age
- Keywords
- Small for gestational age, insulin sensitivity, IGF-1 response, growth hormone treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Birmingham Women's and Children's NHS Foundation Trust, The National Children's Hospital, Tallaght
- Study start
- Nov 2016
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Growth hormone treatment (GH) is recommended in children born small for gestational age (SGA) who fail to catch-up. SGA is a heterogeneous condition as reflected in the varied response to GH treatment. Variable generation and resistance to Insulin-like growth factor-1 (IGF-1), the most important circulating mediator of GH action may underpin this heterogeneity. An association between the variants in the genes related to lower insulin sensitivity and reduced IGF-1 and growth response to GH therapy in SGA children have been reported recently. The hypothesis of this study is that insulin sensitivity may be causally linked to the response to GH therapy, and adjuvant therapy with an insulin sensitizer may improve IGF-1 generation, decrease IGF-I resistance and optimise growth response.
To explore this hypothesis, this study aims to determine the effects of insulin sensitization using Metformin as an adjuvant to a fixed dose GH therapy for 6 months in short SGA children. The patients will be short SGA children between age 4 -10 years and identified from three paediatric endocrine units in Denmark, Ireland and the United Kingdom. In this mechanistic study 24 subjects starting GH treatment will be randomised in a 1:1 ratio to adjunctive Metformin or placebo for 6 months and followed-up for another 6months. The participants will receive GH treatment for the entire duration of the study (12 months) and will undergo an oral glucose tolerance test and dual-energy x-ray absorptiometry scan to determine glucose metabolism and body fat mass respectively at baseline and 6 months, and will have 3 monthly measurements of height, weight and skinfold thickness. The primary outcome will be the area under the curve of IGF-1 levels measured at 0, 1, 3 and 6 months. Secondary outcomes will include changes in insulin sensitivity, height, body fat mass and safety measures at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH+Metformin | Active comparator | Drug: Metformin, Drug: Growth HormoneThe children will be given both Growth Hormone and Metformin for 6 months |
| GH+Placebo | Placebo comparator | Drug: Growth Hormone, Drug: PlaceboChildren will be given both GH and Placebo for 6 months |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Known or suspected allergy to GH
- Previous participation in a GH trial
- Severe learning difficulties
- Previous or active malignancy
- Benign intracranial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin is administered as an oral solution | Drug | GH+Metformin |
| Growth HormoneGrowth Hormone- no specific band | Drug | GH+Metformin, GH+Placebo |
| Placebo | Drug | GH+Placebo |
Primary outcome
IGF-1 response
Time frame: 6 months
Area under the curve of IGF-1 standard deviation scores over 6 months
3 secondary outcomes
Height velocity
Time frame: 6 months and 1 year
Insulin sensitivity
Time frame: 6 months and 1 year
Insulin secretion
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Growth Hormone in people with Small for Gestational Age, run by Cambridge University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David B Dunger, MD (+441223 762944, dbd25@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGF-1 response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.