Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EC08/00160
Study information
Scientific title
Endocrine-metabolic and body composition effects of metformin administration in prepubertal children with a low birthweight for gestational age, postnatal catch-up growth, and risk markers for metabolic syndrome: a double-blind randomised placebo-controlled trial
Acronym
SGA-Met10
Study hypothesis
Administration of metformin for two years in prepubertal children with a history of low birthweight, postnatal catchup and metabolic syndrome will improve insulin sensitivity, and reduce visceral fat and intrahepatic lipid content.
Ethics approval
Hospital Sant Joan de Deu, approved on 08/09/2008 (ref: Act. 98)
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low birthweight, subsequent catchup and metabolic syndrome
Intervention
Participants will be randomly allocated (randomisation ratio 1:1) to receive metformin (oral; 425 mg/day) or placebo over 2 years.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Insulin sensitivity (homeostasis model assessment)
2. Fasting insulin
3. IGF-I
4. Visceral fat
All primary and secondary outcomes will be assessed at 0, 6, 12 and 24 months on metformin, and at 6 months off metformin.
Secondary outcome measures
1. Puberty start (girls)
2. Carotid intima-media thickness
All primary and secondary outcomes will be assessed at 0, 6, 12 and 24 months on metformin, and at 6 months off metformin.
Overall trial start date
15/04/2009
Overall trial end date
15/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Prepubertal children, both males and females
2. Birthweight less or equal to -2.0 SDS for gestational age, at term (37-42 week)
3. Postnatal catchup (weight and height >p25 in the first 2 years of life)
4. Body Mass Index (BMI) >p75 and <p97
5. Increased visceral fat (MR): >p75
6. Insulin-like growth factor-I (IGF-I) levels >p75
7. Fasting insulin >p75
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
52
Participant exclusion criteria
1. Syndromatic, chromosomal, or infectious origin of Small for Gestational Age (SGA)
2. Gestational diabetes
3. Hypothyroidism
4. Systemic disease
5. Precocious pubarche
6. Precocious puberty
Recruitment start date
15/04/2009
Recruitment end date
15/04/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Endocrinology Unit
Barcelona
08950
Spain
Sponsor information
Organisation
Hospital Sant Joan de Deu (Spain)
Sponsor details
c/o Prof Lourdes Ibanez
Endocrinology Unit
University of Barcelona
Esplugues
Barcelona
08950
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: EC08/00160)
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