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

Maria Sandberg Westerstahl

Status: Terminated

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Exercise; Drug: Metformin group

Study type: Interventional

Funder types: Other

Identifiers

NCT00889876

2008-000461-28

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Metformin

Experimental group

Treatment:

Drug: Metformin group

Exercise

Experimental group

Treatment:

Behavioral: Exercise