The LIFE-MET Study: Lifestyle intervention and Metformin in early puberty. A randomized, placebo-controlled study on the effect of insulin sensitization and/or lifestyle intervention on pubertal progression.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511009-50-00

Enrollment

Registered

2024-04-30

Start date

2024-08-27

Completion date

Unknown

Last updated

2025-11-19

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

Conditions

Precocious puberty and overweight

Brief summary

Changes in bone age over 1 year

Detailed description

• Breast development • Sex hormones • HOMA-IR (calculated from fasting insulin and glucose) • Metabolic markers • Body composition • Fitness level • Blood pressure and resting heart rate• Daily physical activity energy expenditure • Quality of Life • Age at menarche

Interventions

DRUGMetformin "Zentiva"

DRUGfilmovertrukne tabletter

DRUGPlacebo to Metformin Zentiva 1000 mg scored tablet

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Changes in bone age over 1 year	—

Secondary

Measure	Time frame
• Breast development • Sex hormones • HOMA-IR (calculated from fasting insulin and glucose) • Metabolic markers • Body composition • Fitness level • Blood pressure and resting heart rate• Daily physical activity energy expenditure • Quality of Life • Age at menarche	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026