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Metformin PharmacoKinetics in young girls

PharmacoKinetics of Metformin at age 9

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49334271
Enrollment
6
Registered
2011-03-15
Start date
2011-03-03
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

Advanced puberty Nutritional, Metabolic, Endocrine Precocious puberty

Interventions

The patients were sampled after being admitted to the hospital,every 45 minutes for 3 hours and then 4, 6, 8, 10 and 12 hours after metformin intake, 850 mg/d. The girls were started on metformin at

Sponsors

Hospital Sant Joan de Déu, University of Barcelona (Spain)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: The study population consisted of 6 non-obese, Caucasian girls receiving metformin (850 mg/d at dinner time) after a history of low-birthweight (Z-score ¡Ü -1.5 for gestational age) and early-normal puberty (onset of Tanner breast stage 2 at age 8 yr; increase of uterine and ovarian size by ultrasound; pubertal gonadotropin response to GnRH agonist).

Exclusion criteria

Exclusion criteria: 1. A family or personal history of diabetes mellitus 2. A history of precocious pubarche or the presence of other signs of androgen excess 3. Evidence for thyroid dysfunction or glucose intolerance 4. Intake of medications known to affect gonadal function or carbohydrate metabolism.

Design outcomes

Primary

MeasureTime frame
1. Height velocity: according to local reference curves: Ferrández-Longás A, Mayayo E, Labarta JI, Bagué L, Puga B, Rueda C, Ruiz-Echarri M, Labena C. Estudio longitudinal de crecimiento y desarrollo. Centro Andrea Prader. Zaragoza 1980-2002. In ERGON, ed. Patrones de crecimiento y desarrollo en España. Atlas de gráficas y tablas., pp 61-115. Madrid: 2004 2. Pubertal status: according to Tanner standards (Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in girls. Arch Dis Child 1969; 44:291-303)

Secondary

MeasureTime frame
1. Bone age: according to Greulich & Pyle 2. Uterine and ovarian size: as measured by ultrasound and according to: Griffin IJ, Cole TJ, Duncan KA, Hollman AS, Donaldson MDC. Pelvic ultrasound measurements in normal girls. Acta Paediatr 1995; 84:536-543

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026