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

February 27, 2009 updated by: Karolinska Institutet

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

213

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, SE 134 40
        • Primary Health Care Center

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

45 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI>25

Exclusion Criteria:

  • Physical impairment
  • Symptomatic angina pectoris
  • Insulin treatment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: at inclusion and after four months
at inclusion and after four months

Secondary Outcome Measures

Outcome Measure
Time Frame
waist circumference
Time Frame: at inclusion and after four months
at inclusion and after four months

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Juleen Zierath, Professor, Dep. of molecular medicine and surgery, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2006

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria

February 26, 2009

First Posted (Estimate)

February 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 2, 2009

Last Update Submitted That Met QC Criteria

February 27, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALF 2006 03 25

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.

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