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

NCT ID: NCT00889876

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2015-12-31

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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Group Type EXPERIMENTAL

Metformin group

Intervention Type DRUG

2000 mg/day for one year

Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Interventions

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Metformin group

2000 mg/day for one year

Intervention Type DRUG

Exercise

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maria Sandberg Westerstahl

OTHER

Sponsor Role lead

Responsible Party

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Maria Sandberg Westerstahl

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Claude Marcus, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet, Karolinska University Hospital Huddinge

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2008-000461-28

Identifier Type: -

Identifier Source: org_study_id

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