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

ISRCTN	ISRCTN06805028
DOI	https://doi.org/10.1186/ISRCTN06805028
Protocol serial number	N/A
Sponsor	Hospital Sant Joan de Deu (Spain)
Funder	Hospital Sant Joan de Déu (Spain)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Lourdes Ibañez
Scientific

Hospital Sant Joan de Déu
University of Barcelona
Esplugues
08950
Spain

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Metformin-Puberty
Study objectives	Modulation of insulin-signalling contributes to variation in the tempo of pubertal progression in girls.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Metformin
Primary outcome measure(s)	1. Menarche 2. Final height
Key secondary outcome measure(s)	1. Fasting insulin 2. IGF-I
Completion date	25/06/2006

Participant type(s)	Patient
Age group	Child
Sex	Female
Target sample size at registration	22
Key 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
Key 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.
Date of first enrolment	20/10/2002
Date of final enrolment	25/06/2006

Hospital Sant Joan de Déu

Esplugues
08950
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2006		Yes	No
Results article	results	01/09/2007		Yes	No