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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00889876
• Other study ID #: 2008-000461-28
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: December 2015

Study information

• Verified date: February 2011
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Metformin group
2000 mg/day for one year

Behavioral:
• Exercise
3 times/week with a personal coach for one year. Endurance training.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Karolinska University Hospital Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sandberg Westerstahl

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of nocturnal blood pressure dipping		Before and 3, 6 and 12 months of intervention
Secondary	Normalization of insulin metabolism and cardiovascular structure and function		Before and 3, 6 and 12 months of intervention