Clinical trial NCT00852982: Exercise Effects on Cardiovascular Risk Factors, Quality of Life, Muscle Function in Type 2 Diabetes and Healthy Persons
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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Impaired Glucose Tolerance
Keywords: Exercise
Risk factors
Primary health care
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 213
Sex: ALL
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* BMI\>25

Exclusion Criteria:

* Physical impairment
* Symptomatic angina pectoris
* Insulin treatment

Primary outcomes:
measure: HbA1c
timeFrame: at inclusion and after four months
Secondary outcomes:
measure: waist circumference
timeFrame: at inclusion and after four months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Primary health care center
Study officials:
affiliation: Dep. of molecular medicine and surgery, Karolinska Institutet
name: Juleen Zierath, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.