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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN06805028

Enrollment

Registered

2005-10-05

Start date

2002-10-20

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced and progressive puberty in low-birthweight girls, resulting in final height below target Urological and Genital Diseases Puberty

Interventions

Insulin sensitisation: metformin 850 mg/day versus placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

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 6 cm/year 5. Progressive puberty, as assessed by pelvic ultrasonography and by gonadotropin and steroid responses to gonadotropin releasing hormone (GnRH) agonist stimulation

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
1. Menarche 2. Final height	—

Secondary

Measure	Time frame
1. Fasting insulin 2. IGF-I	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026