Condition category
Pregnancy and Childbirth
Date applied
12/02/2010
Date assigned
27/05/2010
Last edited
27/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paula Casano

ORCID ID

Contact details

Hospital Sant Joan de Deu
University of Barcelona
Esplugues
Barcelona
08950
Spain

Additional identifiers

EudraCT number

2009-016246-12

ClinicalTrials.gov number

Protocol/serial number

2009-016246-12

Study information

Scientific title

Effects of metformin on cardiovascular risk factors in prepubertal children born small for gestational age without postnatal catch-up growth, currently treated with growth hormone: a prospective randomised clinical trial

Acronym

GH-MET

Study hypothesis

In prepubertal small for gestational age (SGA) children treated with growth hormone (GH), the addition of metformin will have beneficial effects on cardiovascular risk markers and body composition.

Ethics approval

Ethical Committee of Hospital Sant Joan de Deu, University of Barcelona, approved on the 2nd February 2010

Study design

Prospective randomised double-blind two-armed clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Short children born small for gestational age

Intervention

Administration of metformin (425 mg/d) or placebo per oral once daily (at night) over 12 months. Total duration of follow-up is 18 months.

Intervention type

Drug

Phase

Phase II

Drug names

Metformin

Primary outcome measures

Insulin sensitivity (homeostatic model assessment [HOMA]), fasting insulin and visceral fat. An increase in insulin sensitivity (estimated using the HOMA method) equal or greater than 30%, accompanied by a decrease of 10% in visceral fat mass, will be considered a positive and discriminative response.

Measured at baseline, 9 months and 18 months.

Secondary outcome measures

1. Pubertal onset (girls)
2. Insulin-like growth factor-1 (IGF-1)
3. Intima-media thickness (IMT)
4. Lipid profile (triglycerides)
5. Adipokines

Measured at baseline, 9 months and 18 months.

Overall trial start date

01/04/2010

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Prepubertal boys and girls between 7- 10 years old
2. SGA: weight less than or equal to -2 SD for gestational age and gender
3. Full-term pregnancy (gestational age between 37 - 42 weeks)
4. Caucasian origin
5. Prepubertal (Tanner I)
6. GH treatment during the previous 1 - 3 years and currently on treatment at the time of the study
7. Positive response to GH treatment with a 1 SD increase in height velocity

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. Known causes of SGA: congenital infections, genetic syndromes
2. Drug and/or alcohol consumption
3. During the study: liver or kidney disorders or oncological disease
4. Thyroid hormone disorders
5. Obesity (body mass index [BMI] greater than or equal to + 2SD for age), glucose intolerance or type 2 diabetes
6. Treatment with glucocorticoids, sex hormones or drugs that could affect glucose tolerance
7. Infectious or inflammatory symptoms in the 15 days prior to sample collection

Recruitment start date

01/04/2010

Recruitment end date

01/10/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Sant Joan de Deu
Barcelona
08950
Spain

Sponsor information

Organisation

Hospital Sant Joan de Deu (Spain)

Sponsor details

c/o Paula Casano Sancho
University of Barcelona
Esplugues
Barcelona
08950
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.hsjdbcn.org/

Funders

Funder type

Hospital/treatment centre

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) (ref: TRA-131)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes