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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00889876

Enrollment

Registered

2009-04-29

Start date

2009-02-28

Completion date

2015-12-31

Last updated

2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Obesity, Adolescents, Nocturnal blood pressure reduction, Insulin metabolism, Cardiovascular structure and function, Treatment, Exercise, Metformin, Insulin, Blood glucose, Impaired nocturnal blood pressure reduction

Brief summary

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

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.

Interventions

DRUGMetformin group

2000 mg/day for one year

BEHAVIORALExercise

3 times/week with a personal coach for one year. Endurance training.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 19 Years

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

Design outcomes

Primary

Measure	Time frame
Normalization of nocturnal blood pressure dipping	Before and 3, 6 and 12 months of intervention

Secondary

Measure	Time frame
Normalization of insulin metabolism and cardiovascular structure and function	Before and 3, 6 and 12 months of intervention

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026