Use of insulin sensitisers to revert metabolic syndrome

ISRCTN ISRCTN58810841
DOI https://doi.org/10.1186/ISRCTN58810841
Secondary identifying numbers EC08/00160
Submission date
20/02/2009
Registration date
27/02/2009
Last edited
27/02/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lourdes Ibanez
Scientific

Endocrinology Unit
Hospital Sant Joan de Déu
University of Barcelona
Esplugues
Barcelona
08950
Spain

Study information

Study designDouble-blind randomised placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEndocrine-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
Study acronymSGA-Met10
Study objectivesAdministration 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(s)Hospital Sant Joan de Deu, approved on 08/09/2008 (ref: Act. 98)
Health condition(s) or problem(s) studiedLow birthweight, subsequent catchup and metabolic syndrome
InterventionParticipants will be randomly allocated (randomisation ratio 1:1) to receive metformin (oral; 425 mg/day) or placebo over 2 years.
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date15/04/2009
Completion date15/04/2011

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants52
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment15/04/2009
Date of final enrolment15/04/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Endocrinology Unit
Barcelona
08950
Spain

Sponsor information

Hospital Sant Joan de Deu (Spain)
Hospital/treatment centre

c/o Prof Lourdes Ibanez
Endocrinology Unit
University of Barcelona
Esplugues
Barcelona
08950
Spain

http://www.hsjdbcn.org/
ROR logo https://ror.org/001jx2139

Funders

Funder type

Research organisation

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: EC08/00160)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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