The LIFE-MET Study:Lifestyle intervention and Metformin in early puberty.
Phase 1
- Conditions
- Precocious pubertyand overweightTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2024-511009-50-00
- Lead Sponsor
- Herlev Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
•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
Exclusion Criteria
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method