Children and Adolscents with obesity
Conditions
Interventions
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Sponsors
Uppsala county council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent prior to any study-specific procedures. 2. Males or females of age 6 to less than 17 years and 3 months at the time of signing informed consent. 3. Body weight = 40 kg. 4. Obesity (BMI-SDS >2.0) according to WHO. 5. Stable body weight during previous 90 days before screening Visit 1 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known syndromal obesity (e.g. Prader-Willi syndrome, Bardet-Biedl syndrome or Laurence-Moon syndrome). 2. Pregnancy or lactation. 3. Indigestion-causing diseases 4. Severe gastrointestinal disease, as judged by investigator. 5. Total or partial gastric or small intestine resection. 6. Type 1 diabetes mellitus. 7. Kidney disease or renal dysfunction, acute or chronic (eGFR <60ml/min/1,73m2). 8. Hypo-/hyperthyroidism, unless stable treatment. 9. Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by investigator. 10. Severe sleep apnea, as judged by investigator. 11. Chronic disease, as judged by investigator 12. Metformin treatment within 3 months prior to screening or concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product. 13. Steroid treatment (oral or injected). 14. Antidepressants that can lead to weight gain, as judged by investigator. 15. Unstable treatment for neuropsychiatric disorders such as ADHD/ADD, and/or treatment started within 3 months prior to screening visit 16. Known hypersensitivity to metformin or any of the excipients. 17. Language difficulties, impaired mental ability or not willing to understand or comply with the study procedures 18. Participation in another clinical study involving an Investigational Medicinal Product (IMP) within three months prior to screening. 19. Subject from the same household participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect between metformin extended release (XR) plus lifestyle, and lifestyle alone on the BMI-SDS change, from baseline to the 6 months visit at end of treatment.;Secondary Objective: 1.To compare the effect between metformin immediate release (IR) plus lifestyle, and lifestyle alone on the BMI-SDS change, from baseline to the 6 months visit at end of treatment. 2.To evaluate safety and tolerability 3.To compare the effect between metformin immediate release (IR) plus lifestyle and metformin extended release (XR) plus lifestyle on the BMI-SDS change, from baseline to the 6 months visit at end of treatment. 4.To evaluate the effect of plasma (area under the curve (AUC), PK) and urine concentration of metformin XR and metformin IR on the BMI-SDS change from baseline to the 6 months visit at end of treatment 5 To evaluate the effect of age, sex, puberty, duration of obesity and metformin concentration on BMI-SDS change comparing metformin XR and IR and life style alone from baseline to the 6 months visit at end of treatment See protocol for more secondary objectives ;Primary end point(s): BMI-SDS (according to WHO);Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1, 3, 4 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 serum metformin concentration 5.Demographics, tanner stage, and growth chart. Serum and urine concentration of metformin, area under the curve (AUC), PK and BMI-SDS (according to WHO). 7.Glucose and insulin at fasting and during OGTT. Insulin secretion and sensitivity derived from OGTT. HbA1c. 8.Triglycerides, Total cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), SBP and DBP. 9.Creatinine, Cystatin C/GFR, Alanine Aminotransferase (ALAT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD) and Bilirubin. 10.Hs-CRP 11.IGF1, SHBG, FSH, LH Testosteron and Oestradiol 12.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 13.Questionnaires: Food Frequency (FFQ), Regular meals, Portion Size, Physical Activity, Medipal®. 14.PedsQL;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Sweden
Contacts
Public ContactObesity Unit f Children&Adolescents
Uppsala University Children´s hospital
Outcome results
None listed