Type 2 DiabetesSMIDIGNCT00852982
Exercise Effects on Cardiovascular Risk Factors, Quality of Life, Muscle Function in Type 2 Diabetes and Healthy Persons
A study testing Exercise in people with Type 2 Diabetes and Impaired Glucose Tolerance, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 45 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Impaired Glucose Tolerance
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI>25
Who cannot join
- Physical impairment
- Symptomatic angina pectoris
- Insulin treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Impaired Glucose Tolerance
- Being tested
- Exercise
- Keywords
- Exercise, Risk factors, Primary health care
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Nordic walking, with walking poles, five hours per week during four months
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Five hours of Nordic walking per week, during four months Receives: Behavioral: Exercise |
| Control | No intervention | Control group asked not to alter lifestyle during study Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: at inclusion and after four months
Secondary outcomes (1)
waist circumference
Measured: at inclusion and after four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startApr 2006
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Juleen Zierath, Professor, Principal investigator, Dep. of molecular medicine and surgery, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852982
- Sponsor's protocol ID
- ALF 2006 03 25
- Acronym
- SMIDIG
- Status last verified
- Feb 2009
- First submitted
- 26 Feb 2009
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25795414Fritz 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.
PubMed 21658122
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00852982
- Acronym / sponsor ID
- SMIDIG / ALF 2006 03 25
- Conditions
- Type 2 Diabetes, Impaired Glucose Tolerance
- Keywords
- Exercise, Risk factors, Primary health care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseFive hours of Nordic walking per week, during four months |
| Control | No intervention | Behavioral: ExerciseControl group asked not to alter lifestyle during study |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI>25
Key exclusion criteria (3 listed)
- Physical impairment
- Symptomatic angina pectoris
- Insulin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseNordic walking, with walking poles, five hours per week during four months | Behavioural | Control, Exercise |
Primary outcome
HbA1c
Time frame: at inclusion and after four months
1 secondary outcome
waist circumference
Time frame: at inclusion and after four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2009.
- Derived from this study: PubMed 25795414Osler 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.
- Derived from this study: PubMed 21658122Fritz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juleen Zierath, Professor principal investigator
Dep. of molecular medicine and surgery, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Type 2 Diabetes and Impaired Glucose Tolerance, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: at inclusion and after four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2009.