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

Not Applicable

Terminated

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Metformin group; Behavioral: Exercise

• Registration Number: NCT00889876
• Lead Sponsor: Maria Sandberg Westerstahl

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-29
• Status Verified: 2011-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin group	-
Exercise	Exercise	-

Primary Outcome Measures

Name	Time	Method
Normalization of nocturnal blood pressure dipping	Before and 3, 6 and 12 months of intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden