An interventional study of 12-week resistance training in Diabetes Mellitus, Type 2, Polyneuropathy Diabetes and Diabetes Complications, sponsored by Danish Pain Research Center. Completed at 1 site in Denmark. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by Danish Pain Research Center · Not applicable, Interventional, and Other
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 109 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Danish Pain Research Center is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Neuropathy due to any other cause
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 12-week resistance training
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.
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.
Time frame: 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.
Time frame: Change from baseline IENFD at 12 weeks
Plan to share: No
Ran from Aug 2017 to primary completion in Mar 2019, 19 months.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 19 months is close to that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Danish Pain Research Center