Type 2 Diabetes MellitusNCT02366416
Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes
A study testing Exercise training in people with Type 2 Diabetes Mellitus, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the effects og physical exercise on bloodglucose and pain from the musculoskeletal system in patients with type 2 diabetes. The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long term bloodglucose (HbA1c) and pain reported in questionaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Type 2 diabetes
- Must be able to perform physical exercise
Who cannot join
- Participation in structured exercise program within the past three months
- Dementia
- Unable to understand Danish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes and Diabetes Related Complications
The aim of this study is to investigate the effects og physical exercise on bloodglucose and pain from the musculoskeletal system in patients with type 2 diabetes.
The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients will be stratified to patients with a high or a low degree of complications related to diabetes.
Read the detailed description
Design: Uncontrolled intervention study Patients: Type 2 diabetes from Nordsjællands Hospital, Denmark Inclusion critera: adults, type 2 diabetes, not participating in an ungoing exercise program, able to conduct exercise training Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia Intervention: two times one hour exercise training for 12 week. The training will be combined aerobic and resistance training supervised by physiotherapists Outcome: bloodglucose, pain (questionaire) Sample size: 80 participants
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Exercise training
- Keywords
- Exercise, Physical
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Physical activity
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | 12 weeks of one hour exercise training twice weekly Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bloodglucose
HbA1c
Measured: Participants will be followed for a period of 12 weeks physical exercise
Secondary outcomes (1)
Change of musculoskeletal pain
Questionaire
Measured: Participants will be followed for a period of 12 weeks physical exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stig Moelsted, Phd, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366416
- Sponsor's protocol ID
- H-1-2014-122
- Status last verified
- Apr 2018
- First submitted
- 5 Feb 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Molsted S, Tribler J, Snorgaard O. Musculoskeletal pain in patients with type 2 diabetes. Diabetes Res Clin Pract. 2012 May;96(2):135-40. doi: 10.1016/j.diabres.2011.12.022. Epub 2012 Jan 12.
PubMed 22244365Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.
PubMed 21540423Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002968. doi: 10.1002/14651858.CD002968.pub2.
PubMed 16855995Lebiedz-Odrobina D, Kay J. Rheumatic manifestations of diabetes mellitus. Rheum Dis Clin North Am. 2010 Nov;36(4):681-99. doi: 10.1016/j.rdc.2010.09.008.
PubMed 21092846
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Exercise on Blood Glucose and Pain From the Musculoskeletal System in Patients With Type 2 Diabetes and Diabetes Related Complications
- ClinicalTrials.gov ID
- NCT02366416
- Acronym / sponsor ID
- H-1-2014-122
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Exercise, Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 19 Feb 2015 (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.
The aim of this study is to investigate the effects og physical exercise on bloodglucose and pain from the musculoskeletal system in patients with type 2 diabetes.
The patients will be recruited to 12 weeks of exercise twice weekly. The outomes are long term bloodglucose (HbA1c) and pain reported in questionaires. In data analyses the patients will be stratified to patients with a high or a low degree of complications related to diabetes.
Detailed description
Design: Uncontrolled intervention study Patients: Type 2 diabetes from Nordsjællands Hospital, Denmark Inclusion critera: adults, type 2 diabetes, not participating in an ungoing exercise program, able to conduct exercise training Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia Intervention: two times one hour exercise training for 12 week. The training will be combined aerobic and resistance training supervised by physiotherapists Outcome: bloodglucose, pain (questionaire) Sample size: 80 participants
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise training12 weeks of one hour exercise training twice weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 diabetes
- Must be able to perform physical exercise
Key exclusion criteria (3 listed)
- Participation in structured exercise program within the past three months
- Dementia
- Unable to understand Danish language
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 |
|---|---|---|
| Exercise trainingPhysical activity | Behavioural | Exercise training |
Primary outcome
Change of bloodglucose
Time frame: Participants will be followed for a period of 12 weeks physical exercise
HbA1c
1 secondary outcome
Change of musculoskeletal pain
Time frame: Participants will be followed for a period of 12 weeks physical exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 22244365Molsted S, Tribler J, Snorgaard O. Musculoskeletal pain in patients with type 2 diabetes. Diabetes Res Clin Pract. 2012 May;96(2):135-40. doi: 10.1016/j.diabres.2011.12.022. Epub 2012 Jan 12.
- Background: PubMed 21540423Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.
- Background: PubMed 16855995Thomas DE, Elliott EJ, Naughton GA. Exercise for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD002968. doi: 10.1002/14651858.CD002968.pub2.
- Background: PubMed 21092846Lebiedz-Odrobina D, Kay J. Rheumatic manifestations of diabetes mellitus. Rheum Dis Clin North Am. 2010 Nov;36(4):681-99. doi: 10.1016/j.rdc.2010.09.008.
- Individual participant dataSharing planned: Undecided
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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.
Stig Moelsted, Phd principal investigator
Nordsjaellands Hospital
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 training in people with Type 2 Diabetes Mellitus, run by Nordsjaellands Hospital at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 5 Apr 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of bloodglucose (time frame: Participants will be followed for a period of 12 weeks physical exercise). 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 NCT02366416, which also lists 4 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 5 Apr 2018.