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

NCT05585502 | Unknown

• 1 other identifier: PZamparo
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Muscle and tendon disorders; locomotion capacity; passive stretching

Outcome Measures

Primary Outcomes (1)

• Muscle and tendon stiffness differences between T2D patients and controls

  Achilles tendon and muscle (gastrocnemius medialis) stiffness (units: Nm/mm) will be evaluated during isometric maximum voluntary contractions. Torque values (units: Nm) will be recorded using a dynamometer (Cybex Norm) whereas tendon elongation (units: mm) and muscle fascicle displacement (units: mm) will be recorded using an ultrasound scanner (MycrusExt, Telemed).

  Data will be collected at baseline (pre-intervention)

Secondary Outcomes (3)

• Effect of training on muscle and tendon stiffness (in patients and controls)

  Data will be collected at baseline, immediately after the intervention (10 weeks of training) and 5 weeks after the end of the intervention

• Correlation between tissue glycation indicators (AGEs) and muscle-tendon stiffness in T2D patients and controls

  Data will be collected at baseline (pre-intervention)

• Correlation between tissue glycation indicators (RAGE) and muscle-tendon stiffness in T2D patients and controls

  Data will be collected at baseline (pre-intervention)

Study Arms (2)

Training group

EXPERIMENTAL

T2D patients and controls in the experimental group will undergo 50 telemedicine MOS sessions (15 minutes/day, 5 days/week, 10 weeks). Before the training period all subjects will participate to three different experimental sessions: during the first session a blood sample will be withdrawn and a skin biopsy will be taken; during the second session, muscle-tendon stiffness and muscle function will be evaluated; during the third session, the energy cost of walking will be determined at different speeds. After the training period and 5 weeks after the end of the training period, all subjects will repeat the second and the third sessions.

Other: Training (minute oscillation stretching)

Control group

NO INTERVENTION

T2D patients and controls in the control group will not perform any specific training. However, they will participate to the same three sessions as the experimental group.

Interventions

Training (minute oscillation stretching) OTHER

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.

Also known as: Telemedicine training

Training group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• body mass index between 23 and 30 kg/m2
• moderate level of physical activity in the everyday life (assessed by means of the International Physical Activity Questionnaires, IPAQ)

You may not qualify if:

• neuropathy of nondiabetic origin
• severe neuropathy
• foot ulcers
• arterial insufficiency
• arthritis of the ankle/foot
• previous foot/knee surgery
• previous Achille tendon rupture
• previous Charcot foot
• cardiovascular and respiratory deficits that would impede the performance of the locomotion test
• insulin therapy

Sponsors & Collaborators

• Universita di Verona: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• University of Padova: collaborator

Study Sites (1)

Sezione di Scienze Motorie

Verona, 37131, Italy

RECRUITING

Related Publications (10)

• Lapolla A, Traldi P, Fedele D. AGE in micro- and macroangiopathy. Contrib Nephrol. 2001;(131):10-21. doi: 10.1159/000060063. No abstract available.

  PMID: 11125555 BACKGROUND

• Sell DR, Lapolla A, Odetti P, Fogarty J, Monnier VM. Pentosidine formation in skin correlates with severity of complications in individuals with long-standing IDDM. Diabetes. 1992 Oct;41(10):1286-92. doi: 10.2337/diab.41.10.1286.

  PMID: 1397702 BACKGROUND

• Martinelli AR, Mantovani AM, Nozabieli AJ, Ferreira DM, Barela JA, Camargo MR, Fregonesi CE. Muscle strength and ankle mobility for the gait parameters in diabetic neuropathies. Foot (Edinb). 2013 Mar;23(1):17-21. doi: 10.1016/j.foot.2012.11.001. Epub 2012 Dec 27.

  PMID: 23274122 BACKGROUND

• Couppe C, Svensson RB, Kongsgaard M, Kovanen V, Grosset JF, Snorgaard O, Bencke J, Larsen JO, Bandholm T, Christensen TM, Boesen A, Helmark IC, Aagaard P, Kjaer M, Magnusson SP. Human Achilles tendon glycation and function in diabetes. J Appl Physiol (1985). 2016 Jan 15;120(2):130-7. doi: 10.1152/japplphysiol.00547.2015. Epub 2015 Nov 5.

  PMID: 26542519 BACKGROUND

• Petrovic M, Deschamps K, Verschueren SM, Bowling FL, Maganaris CN, Boulton AJM, Reeves ND. Altered leverage around the ankle in people with diabetes: A natural strategy to modify the muscular contribution during walking? Gait Posture. 2017 Sep;57:85-90. doi: 10.1016/j.gaitpost.2017.05.016. Epub 2017 May 19.

  PMID: 28578139 BACKGROUND

• Petrovic M, Maganaris CN, Deschamps K, Verschueren SM, Bowling FL, Boulton AJM, Reeves ND. Altered Achilles tendon function during walking in people with diabetic neuropathy: implications for metabolic energy saving. J Appl Physiol (1985). 2018 May 1;124(5):1333-1340. doi: 10.1152/japplphysiol.00290.2017. Epub 2018 Feb 8.

  PMID: 29420151 BACKGROUND

• Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.

  PMID: 21115758 BACKGROUND

• Colberg SR. Key Points from the Updated Guidelines on Exercise and Diabetes. Front Endocrinol (Lausanne). 2017 Feb 20;8:33. doi: 10.3389/fendo.2017.00033. eCollection 2017. No abstract available.

  PMID: 28265261 BACKGROUND

• Ikeda N, Inami T, Kawakami Y. Stretching Combined with Repetitive Small Length Changes of the Plantar Flexors Enhances Their Passive Extensibility while Not Compromising Strength. J Sports Sci Med. 2019 Feb 11;18(1):58-64. eCollection 2019 Mar.

  PMID: 30787652 BACKGROUND

• Ikeda N, Yonezu T, Kawakami Y. Minute oscillation stretching: A novel modality for reducing musculo-tendinous stiffness and maintaining muscle strength. Scand J Med Sci Sports. 2021 Jan;31(1):104-114. doi: 10.1111/sms.13830. Epub 2020 Oct 7.

  PMID: 32969540 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Tendinopathy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first part of the project is a cross-sectional design to test the association between: diabetic condition -\> increase in muscle and tendon stiffness -\> impairment of muscle-tendon function -\> increase in the energy expenditure of locomotion (walking). The second part of the project is an intervention study that aims to test the effects of a stretching training program on muscle and tendon stiffness, muscle function and locomotor (walking) capacity.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 18, 2022
• Study Start: December 10, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)