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ISRCTN
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ISRCTN06805028
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ClinicalTrials.gov identifier
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Public title
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Insulin sensitisation to delay pubertal progression in girls: a pilot study in small-for-gestational-age (SGA) girls with an early-normal onset of puberty
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Scientific title
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Acronym
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Metformin-Puberty
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Serial number at source
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N/A
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Study hypothesis
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Modulation of insulin-signalling contributes to variation in the tempo of pubertal progression in girls.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Advanced and progressive puberty in low-birthweight girls, resulting in final height below target
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Participants - inclusion criteria
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1. Birthweight for gestational age below -1.5 standard deviation (SD)
2. Onset of breast development (Tanner stage 2, B2) between age 8-9 years and <12 months before study start
3. Height SD score (SDS) at enrollment at least 1 SD above mid-parental height
4. Height velocity >6 cm/year
5. Progressive puberty, as assessed by pelvic ultrasonography and by gonadotropin and steroid responses to gonadotropin releasing hormone (GnRH) agonist stimulation
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Participants - exclusion criteria
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A family or personal history of diabetes mellitus; a history of precocious pubarche; evidence for thyroid dysfunction, Cushing syndrome, hyperprolactinemia or glucose intolerance; medication known to affect gonadal function or carbohydrate metabolism.
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Anticipated start date
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20/10/2002
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Anticipated end date
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25/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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22
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Interventions
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Insulin sensitisation: metformin 850 mg/day versus placebo
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Primary outcome measure(s)
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1. Menarche
2. Final height
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Secondary outcome measure(s)
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1. Fasting insulin
2. IGF-I
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Sources of funding
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Hospital Sant Joan de Déu (Spain)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16492692
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17608755
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Contact name
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Prof
Lourdes
Ibañez
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Address
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Hospital Sant Joan de Déu
University of Barcelona
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City/town
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Esplugues
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Zip/Postcode
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08950
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Country
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Spain
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Sponsor
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Hospital Sant Joan de Deu (Spain)
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Address
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University of Barcelona
Passeig de Sant Joan de Déu, 2
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City/town
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Esplugues
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Zip/Postcode
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08950
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Country
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Spain
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Date applied
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24/08/2005
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Last edited
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11/09/2009
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Date ISRCTN assigned
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05/10/2005
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