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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Karolinska Institutet.
Recruitment status was:  Recruiting
Information provided by:
Karolinska Institutet Identifier:
First received: April 27, 2009
Last updated: February 3, 2011
Last verified: February 2011
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.

Condition Intervention
Cardiovascular Diseases Drug: Metformin group Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Normalization of nocturnal blood pressure dipping [ Time Frame: Before and 3, 6 and 12 months of intervention ]

Secondary Outcome Measures:
  • Normalization of insulin metabolism and cardiovascular structure and function [ Time Frame: Before and 3, 6 and 12 months of intervention ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00889876

Contact: Claude Marcus, Professor +468 585 814 19
Contact: Maria Westerstahl, PhD +468 585 873 96

Karolinska Institutet, Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden, 141 86
Contact: Maria Westerståhl, PhD    +468 585 873 96   
Contact: Pernilla Hedvall, PhDstudent    +468 585 873 96   
Principal Investigator: Claude Marcus, Professor         
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Claude Marcus, Professor Karolinska Institutet
  More Information

Responsible Party: Professor Claude Marcus, Karolinska Institutet, Karolinska Institutet Identifier: NCT00889876     History of Changes
Other Study ID Numbers: 2008-000461-28
Study First Received: April 27, 2009
Last Updated: February 3, 2011

Keywords provided by Karolinska Institutet:
Nocturnal blood pressure reduction
Insulin metabolism
Cardiovascular structure and function
Blood glucose
Impaired nocturnal blood pressure reduction

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017