Metformin Intervention in children and adolescents with obesity. A parallel, three arms, randomized, 6 months, multi-center study with metformin extended release (XR) plus lifestyle or metformin immediate release (IR) plus lifestyle or lifestyle alone.

Conditions

Children and Adolscents with obesity.

Brief summary

BMI-SDS (according to WHO).

Detailed description

1 and 3: BMI-SDS (according to WHO)., 2. Adverse Events, vital signs (systolic and diastolic blood pressure (SBP and DBP) and heart rate), physical examination, fP-glucose, ALAT, creatinine, lactate, cobalamin, clinical chemistry, haematology and urine analysis and plasma metformin concentration., 4. Plasma and urine concentration of metformin (PK), area under the curve (AUC), BMI-SDS (according to WHO)., 5. Demographics, tanner stage, anthropometrics and growth chart. Plasma and urine concentration of metformin (PK), area under the curve (AUC) and BMI-SDS (according to WHO)., 6. Glucose and insulin at fasting and during OGTT. Insulin secretion and sensitivity derived from OGTT. HbA1c., 7. Triglycerides, Total cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), SBP and DBP., 8. Creatinine, Cystatin C/GFR, Alanine Aminotransferase (ALAT), Gamma Glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LD) and Bilirubin., 9. Hs-CRP., 10. IGF-1, SHBG, FSH, LH, Testosterone and Estrogen., 11. Anthropometrics, waist- and hip circumference (including ratio), and sagittal abdominal diameter (SAD). Bioimpedance, indirect calorimetry and skin fold measurement will be performed at selected sites, 12. Questionnaires: Food Frequency (FFQ), Regular meals, Portion Size, Physical Activity, Medipal®., 13. PedsQL™.

Related papers

No related papers found yet.

Interventions

DRUGGLUCOPHAGE 500 mg film-coated tablets

DRUGGlucophage SR 500mg prolonged release tablet

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
BMI-SDS (according to WHO).	—

Secondary

Measure	Time frame
1 and 3: BMI-SDS (according to WHO)., 2. Adverse Events, vital signs (systolic and diastolic blood pressure (SBP and DBP) and heart rate), physical examination, fP-glucose, ALAT, creatinine, lactate, cobalamin, clinical chemistry, haematology and urine analysis and plasma metformin concentration., 4. Plasma and urine concentration of metformin (PK), area under the curve (AUC), BMI-SDS (according to WHO)., 5. Demographics, tanner stage, anthropometrics and growth chart. Plasma and urine concentration of metformin (PK), area under the curve (AUC) and BMI-SDS (according to WHO)., 6. Glucose and insulin at fasting and during OGTT. Insulin secretion and sensitivity derived from OGTT. HbA1c., 7. Triglycerides, Total cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), SBP and DBP., 8. Creatinine, Cystatin C/GFR, Alanine Aminotransferase (ALAT), Gamma Glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LD) and Bilirubin., 9. Hs-CRP., 10. IGF-1, SHBG, FSH, LH, Testoste	—

Measure

Time frame

1 and 3: BMI-SDS (according to WHO)., 2. Adverse Events, vital signs (systolic and diastolic blood pressure (SBP and DBP) and heart rate), physical examination, fP-glucose, ALAT, creatinine, lactate, cobalamin, clinical chemistry, haematology and urine analysis and plasma metformin concentration., 4. Plasma and urine concentration of metformin (PK), area under the curve (AUC), BMI-SDS (according to WHO)., 5. Demographics, tanner stage, anthropometrics and growth chart. Plasma and urine concentration of metformin (PK), area under the curve (AUC) and BMI-SDS (according to WHO)., 6. Glucose and insulin at fasting and during OGTT. Insulin secretion and sensitivity derived from OGTT. HbA1c., 7. Triglycerides, Total cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), SBP and DBP., 8. Creatinine, Cystatin C/GFR, Alanine Aminotransferase (ALAT), Gamma Glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LD) and Bilirubin., 9. Hs-CRP., 10. IGF-1, SHBG, FSH, LH, Testoste

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Countries

Sweden

Outcome results

None listed