Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for CVD Among Obese Adolescents

Study Overview
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Brief Summary
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The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.

Detailed Description
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Forty subjects will be assigned to the exercise intervention group, thirty to the metformin therapy group and thirty to the control group. Group I will be treated daily with metformin. Group II will perform exercise (endurance) three times/week with a personal coach and group III will serve as control. All participants will be examined at baseline, after 3 months of intervention, after 6 months of intervention and after one year of intervention. Examination includes anthropometric measures, measures of ambulatory 24-h blood pressure and insulin sensitivity, measures for function and structure of the heart and vessels, analysis of atherogenic factors in the blood, aerobic fitness testing and measurement of daily physical activity.

Official Title
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Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Metformin group
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 13-19 years old at inclusion date Obesity according to gender and age specific BMI (Cole 2000) Reduced nocturnal systolic blood pressure fall (< 10%) Signed informed consent by patient and parents Exclusion Criteria: Cardiovascular disease Insulin dependent diabetes mellitus Patient on medications that are contraindicated during Metformin treatment Pregnancy Mental or physical conditions limiting the ability to participate

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br> | Drug: Metformin group<br>* 2000 mg/day for one year<br>|
| Experimental: Exercise<br> | Behavioral: Exercise<br>* 3 times/week with a personal coach for one year. Endurance training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of nocturnal blood pressure dipping |  | Before and 3, 6 and 12 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of insulin metabolism and cardiovascular structure and function |  | Before and 3, 6 and 12 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Adolescents, Nocturnal blood pressure reduction, Insulin metabolism, Cardiovascular structure and function, Treatment, Exercise, Metformin, Insulin, Blood glucose, Impaired nocturnal blood pressure reduction