Use of insulin sensitisers to revert metabolic syndrome

Endocrine-metabolic and body composition effects of metformin administration in prepubertal children with a low birthweight for gestational age, postnatal catch-up growth, and risk markers for metabolic syndrome: a double-blind randomised placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN58810841

Enrollment

Registered

2009-02-27

Start date

2009-04-15

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

Low birthweight, subsequent catchup and metabolic syndrome Pregnancy and Childbirth Disorders related to short gestation and low birth weight, not elsewhere classified

Interventions

Participants will be randomly allocated (randomisation ratio 1:1) to receive metformin (oral

425 mg/day) or placebo over 2 years.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Prepubertal children, both males and females 2. Birthweight less or equal to -2.0 SDS for gestational age, at term (37-42 week) 3. Postnatal catchup (weight and height >p25 in the first 2 years of life) 4. Body Mass Index (BMI) >p75 and p75 6. Insulin-like growth factor-I (IGF-I) levels >p75 7. Fasting insulin >p75

Exclusion criteria

Exclusion criteria: 1. Syndromatic, chromosomal, or infectious origin of Small for Gestational Age (SGA) 2. Gestational diabetes 3. Hypothyroidism 4. Systemic disease 5. Precocious pubarche 6. Precocious puberty

Design outcomes

Primary

Measure	Time frame
1. Insulin sensitivity (homeostasis model assessment) 2. Fasting insulin 3. IGF-I 4. Visceral fat All primary and secondary outcomes will be assessed at 0, 6, 12 and 24 months on metformin, and at 6 months off metformin.	—

Secondary

Measure	Time frame
1. Puberty start (girls) 2. Carotid intima-media thickness All primary and secondary outcomes will be assessed at 0, 6, 12 and 24 months on metformin, and at 6 months off metformin.	—

Countries

Spain

Outcome results

None listed

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