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) MedDRA version: 9.1 Level: LLT Classification code 10065226 Term: Non-dipping MedDRA version: 9.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome
Conditions
Interventions
Trade Name: For example Glucophage, see D2.2
Product Name: metformin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115704
Concentration unit: mg milligra
Sponsors
Karolinska institutet
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;Primary end point(s): Results of 12 months treatment (exercise/metformin/control) on nocturnal dipping | — |
Countries
Sweden
Outcome results
None listed