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The LIFE-MET Study: Lifestyle intervention and Metformin in early puberty.
EU CTIS ID: 2024-511009-50-00
What this study is testing
To determine the effects of either insulin sensitization during Metformin treatment or changes in body composition during lifestyle intervention for 6 months on bone age as a marker of pubertal maturation in girls with overweight and early puberty.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Girls aged 8-9.5 years • Breast development on clinical examination (≥Tanner B2) • GnRH test with stimulated LH>5 IU/l or non-stimulated LH>3 IU/L • BMI > 91st percentile/+1.34 SDs • Premenarcheal
You likely can't join if
- • Known or suspected hypersensitivity or allergy to Metformin • Diabetes Mellitus (type 1 or 2) • Previous or active malignancy • Cardiac, pulmonary, hepatic, or renal diseases associated with significant decompensation • Psychological problems likely to lead to significant non-compliance
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.