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

March 31, 2023 updated by: Maria Sandberg Westerstahl

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Karolinska Institutet, Karolinska University Hospital Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Drug: Metformin group
2000 mg/day for one year
Experimental: Exercise
Behavioral: Exercise
3 times/week with a personal coach for one year. Endurance training.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sandberg Westerstahl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-000461-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe