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

Completed

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

• Registration Number: ISRCTN06805028
• Lead Sponsor: Hospital Sant Joan de Deu (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 22

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Menarche<br>2. Final height

Secondary Outcome Measures

Name	Time	Method
1. Fasting insulin<br>2. IGF-I