Back to resultsExercise Effects on Cardiovascular Risk Factors, Quality of Life, Muscle Function in Type 2 Diabetes and Healthy Persons (SMIDIG)
Primary Purpose
Type 2 Diabetes, Impaired Glucose Tolerance
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring Exercise, Risk factors, Primary health care
Eligibility Criteria
Inclusion Criteria:
- BMI>25
Exclusion Criteria:
- Physical impairment
- Symptomatic angina pectoris
- Insulin treatment
Sites / Locations
- Primary health care center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
Five hours of Nordic walking per week, during four months
Control group asked not to alter lifestyle during study
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
waist circumference
Full Information
NCT ID
NCT00852982
First Posted
February 26, 2009
Last Updated
February 27, 2009
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT00852982
Brief Title
Exercise Effects on Cardiovascular Risk Factors, Quality of Life, Muscle Function in Type 2 Diabetes and Healthy Persons
Acronym
SMIDIG
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Impaired Glucose Tolerance
Keywords
Exercise, Risk factors, Primary health care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Five hours of Nordic walking per week, during four months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group asked not to alter lifestyle during study
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Nordic walking, with walking poles, five hours per week during four months
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
at inclusion and after four months
Secondary Outcome Measure Information:
Title
waist circumference
Time Frame
at inclusion and after four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>25
Exclusion Criteria:
Physical impairment
Symptomatic angina pectoris
Insulin treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juleen Zierath, Professor
Organizational Affiliation
Dep. of molecular medicine and surgery, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary health care center
City
Stockholm
ZIP/Postal Code
SE 134 40
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
25795414
Citation
Osler ME, Fritz T, Caidahl K, Krook A, Zierath JR, Wallberg-Henriksson H. Changes in gene expression in responders and nonresponders to a low-intensity walking intervention. Diabetes Care. 2015 Jun;38(6):1154-60. doi: 10.2337/dc14-2606. Epub 2015 Mar 20.
Results Reference
derived
PubMed Identifier
21658122
Citation
Fritz T, Caidahl K, Osler M, Ostenson CG, Zierath JR, Wandell P. Effects of Nordic walking on health-related quality of life in overweight individuals with type 2 diabetes mellitus, impaired or normal glucose tolerance. Diabet Med. 2011 Nov;28(11):1362-72. doi: 10.1111/j.1464-5491.2011.03348.x.
Results Reference
derived
Learn more about this trial
Exercise Effects on Cardiovascular Risk Factors, Quality of Life, Muscle Function in Type 2 Diabetes and Healthy Persons
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