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

Type 2 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00852982
• Other study ID #: ALF 2006 03 25
• Status: Active, not recruiting
• Phase: N/A
• First received: February 26, 2009
• Last updated: February 27, 2009
• Start date: April 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 213
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 69 Years

Eligibility

Inclusion Criteria:

• BMI>25

Exclusion Criteria:

• Physical impairment

• Symptomatic angina pectoris

• Insulin treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Type 2 Diabetes

Intervention

Behavioral:
• Exercise
Nordic walking, with walking poles, five hours per week during four months

Locations

Country	Name	City	State
Sweden	Primary health care center	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		at inclusion and after four months	No
Secondary	waist circumference		at inclusion and after four months	No