Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Metformin-Puberty
Study hypothesis
Modulation of insulin-signalling contributes to variation in the tempo of pubertal progression in girls.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Advanced and progressive puberty in low-birthweight girls, resulting in final height below target
Intervention
Insulin sensitisation: metformin 850 mg/day versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Metformin
Primary outcome measures
1. Menarche
2. Final height
Secondary outcome measures
1. Fasting insulin
2. IGF-I
Overall trial start date
20/10/2002
Overall trial end date
25/06/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Female
Target number of participants
22
Participant exclusion criteria
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.
Recruitment start date
20/10/2002
Recruitment end date
25/06/2006
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Sant Joan de Déu
Esplugues
08950
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital Sant Joan de Déu (Spain)
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16492692
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17608755
Publication citations
-
Results
Ibáñez L, Valls C, Ong K, Dunger DB, de Zegher F, Metformin therapy during puberty delays menarche, prolongs pubertal growth, and augments adult height: a randomized study in low-birth-weight girls with early-normal onset of puberty., J. Clin. Endocrinol. Metab., 2006, 91, 6, 2068-2073, doi: 10.1210/jc.2005-2329.
-
Results
Ong K, de Zegher F, Valls C, Dunger DB, Ibáñez L, Persisting benefits 12-18 months after discontinuation of pubertal metformin therapy in low birthweight girls., Clin. Endocrinol. (Oxf), 2007, 67, 3, 468-471, doi: 10.1111/j.1365-2265.2007.02952.x.