E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The aim is to, among obese adolescents study impact of exercise or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors (e.g. insulin sensitivity, IMT, LVM, endothelian function) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065226 |
E.1.2 | Term | Non-dipping |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052066 |
E.1.2 | Term | Metabolic syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To, among obese adolescents study impact of regular physical activity or metformin therapy on nocturnal blood pressure. We hypothesise that increased levels of exercise or metformin therapy over a period of 12 months will improve nocturnal blood pressure. |
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E.2.2 | Secondary objectives of the trial |
To, among obese adolescents study -effect of treatment (exercise or metformin) on cardiovascular disease risk factors as IMT, glucose metabolism and insulin sensitivity compared to standard treatment at the clinic -compliance with metformin treatment compared to physical intervention program focusing on individual recommendations and support. -effect of treatment (exercise or metformin) on quality of life compared standard treatment at the clinic
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Only patients meeting all the following criteria (a-e) will be included in the study. a) Patient at the paediatric outpatient clinic at Karolinska university hospital, Huddinge, Södertälje or Liljeholmen b) Age 13-19 years old at inclusion date c) Obesity according to gender and age specific BMI (Cole 2000) d) Completed 24hour blood pressure recording e) Signed informed consent by patient and parents |
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E.4 | Principal exclusion criteria |
Adolescents showing any of criteria a-d. will not be included in the study a) Hypertension requiring drug treatment b) Insulin dependent diabetes mellitus c) Patient on medications that are contraindicated during Metformin treatment d) Patient on medication affecting metabolism or body weight e) Pregnancy f) Mental or physical conditions limiting the ability to participate g) Severe liver or renal impairment |
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E.5 End points |
E.5.1 | Primary end point(s) |
Results of 12 months treatment (exercise/metformin/control) on nocturnal dipping
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
exercise or no treatment (control) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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100 persons included (of which 30 in the metformin group) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |