Diabetes Mellitus, Type 2NCT03252132
Resistance Training in Patients With Diabetic Neuropathy
A study testing 12-week resistance training in people with Diabetes Mellitus, Type 2 and Polyneuropathy Diabetes, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2). Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Polyneuropathy Diabetes, Diabetes Complications
- What is being tested?
- 12-week resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2017to 31 Mar 2019
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 2 diabetes
Who cannot join
- Neuropathy due to any other cause
- BMI >40
- Pacemaker
- Comorbidity that contraindicates exercise
- History of stroke with affection of the lower extremities
- Ischemic heart disease
- Any other neurological disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).
Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural instability increasing the risk of frequent falls and thereby increased morbidity and mortality. Thus, diabetic neuropathy is associated with significant disabilities having major impact on activities of daily living and quality of life.
The effects of resistance training on neuropathy symptoms, muscle strength and muscle structure in patients with and with diabetic neuropathy will be examined.
Read the detailed description
Perspective: The studies will likely improve the understanding of diabetic neuropathy and the relation between risk of falls in patients with and without motor dysfunction. The results may enable new and more precise recommendations for exercise in diabetic patients with diabetic neuropathy. In addition, the results may lead to a better understanding of the mechanisms underlying the effects of training. The improvement of motor function may lead to improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes patients, resulting in lower morbidity and mortality.
- Conditions
- Diabetes Mellitus, Type 2, Polyneuropathy Diabetes, Diabetes Complications, Diabetic Peripheral Neuropathy, Muscle Weakness, Fall Patients
- Being tested
- 12-week resistance training
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies, Diabetes Complications, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week resistance trainingOther
Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.
| Study group | Role | What they receive |
|---|---|---|
| 12-week resistance training | Active comparator | Not described Receives: Other: 12-week resistance training |
| No training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraepidermal nerve fiber density (IENFD)
1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.
Measured: Change from baseline IENFD at 12 weeks
Muscle strength (isokinetic strength)
Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.
Measured: Change from baseline IENFD at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start10 Aug 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, randomized controlled training trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Karolina Snopek, MD, Principal investigator, Danish Pain Research Center, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252132
- Sponsor's protocol ID
- IDNC-DD2-MUSCLE
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan KS, Overgaard K, Tankisi H, Karlsson P, Devantier L, Gregersen S, Jensen TS, Finnerup NB, Pop-Busui R, Dalgas U, Andersen H. Effects of progressive resistance training in individuals with type 2 diabetic polyneuropathy: a randomised assessor-blinded controlled trial. Diabetologia. 2022 Apr;65(4):620-631. doi: 10.1007/s00125-021-05646-6. Epub 2022 Jan 19.
PubMed 35048156
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT03252132
- Acronym / sponsor ID
- IDNC-DD2-MUSCLE
- Conditions
- Diabetes Mellitus, Type 2, Polyneuropathy Diabetes, Diabetes Complications, Diabetic Peripheral Neuropathy, Muscle Weakness, Fall Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Aug 2017 (actual)
- 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.
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).
Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural instability increasing the risk of frequent falls and thereby increased morbidity and mortality. Thus, diabetic neuropathy is associated with significant disabilities having major impact on activities of daily living and quality of life.
The effects of resistance training on neuropathy symptoms, muscle strength and muscle structure in patients with and with diabetic neuropathy will be examined.
Detailed description
Perspective: The studies will likely improve the understanding of diabetic neuropathy and the relation between risk of falls in patients with and without motor dysfunction. The results may enable new and more precise recommendations for exercise in diabetic patients with diabetic neuropathy. In addition, the results may lead to a better understanding of the mechanisms underlying the effects of training. The improvement of motor function may lead to improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes patients, resulting in lower morbidity and mortality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- International, randomized controlled training trial
| Arm | Type | Receives |
|---|---|---|
| 12-week resistance training | Active comparator | Other: 12-week resistance training |
| No training | No intervention | – |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of type 2 diabetes
Key exclusion criteria (8 listed)
- Neuropathy due to any other cause
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 |
|---|---|---|
| 12-week resistance trainingTraining will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip. | Other | 12-week resistance training |
Primary outcome
Intraepidermal nerve fiber density (IENFD)
Time frame: Change from baseline IENFD at 12 weeks
1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.
Muscle strength (isokinetic strength)
Time frame: Change from baseline IENFD at 12 weeks
Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.
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 19 Aug 2021.
- Derived from this study: PubMed 35048156Khan KS, Overgaard K, Tankisi H, Karlsson P, Devantier L, Gregersen S, Jensen TS, Finnerup NB, Pop-Busui R, Dalgas U, Andersen H. Effects of progressive resistance training in individuals with type 2 diabetic polyneuropathy: a randomised assessor-blinded controlled trial. Diabetologia. 2022 Apr;65(4):620-631. doi: 10.1007/s00125-021-05646-6. Epub 2022 Jan 19.
- Individual participant dataSharing planned: No
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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.
Karolina Snopek, MD principal investigator
Danish Pain Research Center, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week resistance training in people with Diabetes Mellitus, Type 2 and Polyneuropathy Diabetes, run by Danish Pain Research Center 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 1 inclusion and 8 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 19 Aug 2021. 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?
Intraepidermal nerve fiber density (IENFD) (time frame: Change from baseline IENFD at 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03252132, which also lists 1 linked publication.
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 19 Aug 2021.