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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 because the information has not been verified recently.
Verified February 2011 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00889876
First received: April 27, 2009
Last updated: February 3, 2011
Last verified: February 2011
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Normalization of insulin metabolism and cardiovascular structure and function [ Time Frame: Before and 3, 6 and 12 months of intervention ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889876

Contacts
Contact: Claude Marcus, Professor +468 585 814 19 claude.marcus@ki.se
Contact: Maria Westerstahl, PhD +468 585 873 96 maria.westerstahl@ki.se

Locations
Sweden
Karolinska Institutet, Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden, 141 86
Contact: Maria Westerståhl, PhD     +468 585 873 96     maria.westerstahl@ki.se    
Contact: Pernilla Hedvall, PhDstudent     +468 585 873 96     pernilla.hedvall@ki.se    
Principal Investigator: Claude Marcus, Professor            
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Claude Marcus, Professor Karolinska Institutet
  More Information

No publications provided

Responsible Party: Professor Claude Marcus, Karolinska Institutet, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00889876     History of Changes
Other Study ID Numbers: 2008-000461-28
Study First Received: April 27, 2009
Last Updated: February 3, 2011
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013