NCT03252132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

August 10, 2017

Last Update Submit

August 17, 2021

Conditions

Diabetes Mellitus, Type 2Polyneuropathy DiabetesDiabetes ComplicationsDiabetic Peripheral NeuropathyMuscle WeaknessFall Patients

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Change from baseline IENFD at 12 weeks

Study Arms (2)

12-week resistance training

ACTIVE COMPARATOR
Other: 12-week resistance training

No training

NO INTERVENTION

Interventions

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.

12-week resistance training

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 35048156DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic NeuropathiesDiabetes ComplicationsMuscle Weakness

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karolina Snopek, MD

    Danish Pain Research Center, Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: International, randomized controlled training trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 17, 2017

Study Start

August 10, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)