Exercise Effects on Cardiovascular Risk Factors, Quality of Life, Muscle Function in Type 2 Diabetes and Healthy Persons (SMIDIG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Karolinska Institutet.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00852982
First received: February 26, 2009
Last updated: February 27, 2009
Last verified: February 2009
  Purpose

A sedentary lifestyle is known to be a risk factor to developing type 2 diabetes. The aim of this study was to determine the effects of adding regular Nordic walking to daily physical activity. Effects on quality of life, cardiovascular risk factors and functions in muscle cells will be determined.


Condition Intervention
Type 2 Diabetes
Impaired Glucose Tolerance
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exercise - Effects on Health Related Quality of Life, Cardiovascular Risk Factors, and Cellular Functions With Respect to Glucose Metabolism, in Type 2 Diabetes Mellitus, Impaired Glucose Tolerance and in Healthy Individuals.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • HbA1c [ Time Frame: at inclusion and after four months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • waist circumference [ Time Frame: at inclusion and after four months ] [ Designated as safety issue: No ]

Estimated Enrollment: 213
Study Start Date: April 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Five hours of Nordic walking per week, during four months
Behavioral: Exercise
Nordic walking, with walking poles, five hours per week during four months
No Intervention: Control
Control group asked not to alter lifestyle during study
Behavioral: Exercise
Nordic walking, with walking poles, five hours per week during four months

Detailed Description:

Regular physical activity is known to have a beneficial effect on several factors affecting the risk of developing cardiovascular disease and type 2 diabetes. Implementing and maintaining changes of lifestyle is, however, known to be difficult. In this study we wished to investigate the effects of an exercise intervention that is feasible to most people with type 2 diabetes or at risk of developing that disease. The intervention was Nordic walking (with walking poles) for five hour per week, during four months. We chose to determine effects on health related quality of life, clinical parameters related to body weight/body composition, blood pressure, glucose metabolism, insulin resistance, blood lipids, oxygen uptake and physiological effects in skeletal muscle cells related to glucose metabolism.

On inclusion and after four months the participants were therefore subject to clinical measurements, blood samples, maximal oxygen uptake tests on an ergometer cycle and muscle biopsies at inclusion and after four months of participation. They also answered an extensive questionnaire focusing on health related quality of life.

  Eligibility

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI>25

Exclusion Criteria:

  • Physical impairment
  • Symptomatic angina pectoris
  • Insulin treatment
  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 ClinicalTrials.gov identifier: NCT00852982

Locations
Sweden
Primary health care center
Stockholm, Sweden, SE 134 40
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Juleen Zierath, Professor Dep. of molecular medicine and surgery, Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juleen Zierath , Professor, Dep. of molecular medicine and surgery, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00852982     History of Changes
Other Study ID Numbers: ALF 2006 03 25
Study First Received: February 26, 2009
Last Updated: February 27, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Exercise
Risk factors
Primary health care

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on July 26, 2014