Clinical trial NCT03252132: Resistance Training in Patients With Diabetic Neuropathy
Official title: Resistance Training in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Polyneuropathy Diabetes
Diabetes Complications
Diabetic Peripheral Neuropathy
Muscle Weakness
Fall Patients
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2017-08-17
Enrollment: 109
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International, randomized controlled training trial
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intraepidermal nerve fiber density (IENFD)
timeFrame: Change from baseline IENFD at 12 weeks
measure: Muscle strength (isokinetic strength)
timeFrame: Change from baseline IENFD at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center, Aarhus University
name: Karolina Snopek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.