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Impact of Muscle and Tendon Dysfunction in People With Type 2 Diabetes Mellitus

NCT05585502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-05-09

No results posted yet for this study

Summary

Diabetes is a chronic-degenerative metabolic disorder that has reached pandemic proportions mainly because of the increasing incidence and prevalence of type 2 diabetes mellitus (T2D).

Diabetes hurts cardiovascular function due to chronic hyperinsulinemia and hyperglycemia, along with increased advanced glycation end products (AGEs) causing nonenzymatic glycation of soft tissues, including muscle and tendon, and leading to an increase in muscle and tendon stiffness. In turn, the stiffening of the muscle-tendon complex reduces its capability to change in shape, affecting its potential for modulating the mechanical request during contraction (and locomotion), also increasing the metabolic demands during walking.

The present, multi-disciplinary, project combines several experimental methods and procedures to investigate the impact of muscle and tendon alterations on the mechanics of muscle contraction and locomotion capacity in T2D patients. In this project, we also propose a new training approach (minute oscillation stretching) to counteract these possible alterations (e.g. to decrease muscle and tendon stiffness).

Conditions

Interventions

OTHER

Training (minute oscillation stretching)

The training session involves the use of an elastic band that the subjects will use to induce passive ankle flexion /extensions (with a frequency of 1 Hz): 10 repetitions will be performed with 60 s exercise and 30 s of pause in-between. At the end of the session, the subjects will fill a diary with data of perceived intensity of exercise and localized ankle pain. The telemedicine session will be conducted by trained personnel.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER

  • University of Padova

    collaborator OTHER

  • Universita di Verona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-10
Primary Completion
2023-10-31
Completion
2024-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585502 on ClinicalTrials.gov