Prepubertal insulin sensitisation in girls with a combined history of low birthweight and precocious pubarche

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84749320

Enrollment

Registered

2005-10-05

Start date

2002-10-10

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

Precocious pubarche Urological and Genital Diseases Precocious pubarche

Interventions

Randomised subgroups: 1. Metformin 425 mg/day 2. Untreated Added as of 11/07/2008: Cross-over of therapy from year 6 of follow-up. All patients have been off therapy from year 5 (July 2007) to year

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Girls with a combined history of low birthweight (less than 1.5 standard deviation score [SDS]) and precocious pubarche (appearance of pubic hair before age 8)

Exclusion criteria

Exclusion criteria: 1. Congenital adrenal hyperplasia 2. Diabetes mellitus 3. Thyroid dysfunction

Design outcomes

Primary

Measure	Time frame
Onset of puberty, measured at baseline and every 6 months (timepoints added 11/07/2008)	—

Secondary

Measure	Time frame
1. Menarche, measured baseline and every 6 months. All untreated girls are already menarcheal, 14 of 19 treated girls are mernarcheal. 2. Final height, measured end of the 6th year Timepoints added 11/07/2008	—

Countries

Spain

Outcome results

None listed

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