Addition of metformin to growth hormone for short children born small for gestational age

Completed

• Conditions: Short children born small for gestational age; Pregnancy and Childbirth; Slow fetal growth and fetal malnutrition

• Registration Number: ISRCTN19548431
• Lead Sponsor: Hospital Sant Joan de Deu (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Prepubertal boys and girls between 7- 10 years old
2. SGA: weight less than or equal to -2 SD for gestational age and gender
3. Full-term pregnancy (gestational age between 37 - 42 weeks)
4. Caucasian origin
5. Prepubertal (Tanner I)
6. GH treatment during the previous 1 - 3 years and currently on treatment at the time of the study
7. Positive response to GH treatment with a 1 SD increase in height velocity

Exclusion Criteria

1. Known causes of SGA: congenital infections, genetic syndromes
2. Drug and/or alcohol consumption
3. During the study: liver or kidney disorders or oncological disease
4. Thyroid hormone disorders
5. Obesity (body mass index [BMI] greater than or equal to + 2SD for age), glucose intolerance or type 2 diabetes
6. Treatment with glucocorticoids, sex hormones or drugs that could affect glucose tolerance
7. Infectious or inflammatory symptoms in the 15 days prior to sample collection

Study & Design

• Study Type: Interventional
• Study Design: Not specified