Condition category
Pregnancy and Childbirth
Date applied
20/02/2009
Date assigned
27/02/2009
Last edited
27/02/2009
Prospective/Retrospective
Prospectively 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

Prof Lourdes Ibanez

ORCID ID

Contact details

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

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

http://www.hsjdbcn.org/

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

Publication citations

Additional files

Editorial Notes