Type 2 Diabetes MellitusT2D_MTUNCT05585502
Impact of Muscle and Tendon Dysfunction in People With Type 2 Diabetes Mellitus
A study testing Training (minute oscillation stretching) in people with Type 2 Diabetes Mellitus, run by Universita di Verona at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Training (minute oscillation stretching)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- neuropathy of nondiabetic origin
- severe neuropathy
- foot ulcers
- arterial insufficiency
- arthritis of the ankle/foot
- previous foot/knee surgery
Show all 10Show fewer
- previous Achille tendon rupture
- previous Charcot foot
- cardiovascular and respiratory deficits that would impede the performance of the locomotion test
- insulin therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Muscle and Tendon Dysfunction on the Mechanics of Muscle Contraction and Locomotion Capacity in People With Type 2 Diabetes Mellitus, and Efficacy of a Passive Stretching Training Program to Counteract These Alterations
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).
Read the detailed description
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). According to the International Diabetes Federation (IDF, 2017), 425 million people suffer from diabetes worldwide and these may rise to 629 million in 2045 . Within this epidemiological perspective, diabetes emerges as one of the main metabolic disorders with substantial costs for regional and national sanitary systems.
Diabetes hurts cardiovascular function due to chronic hyperinsulinemia and hyperglycemia, along with increased advanced glycation end products (AGEs), pro-inflammatory cytokines, oxidative stress, obesity, dyslipidemia, and physical inactivity, all of which contribute to vascular dysfunction. In particular, several studies have shown that AGEs exert their negative effects through binding to a specific cellular receptor (RAGE), found in several cell systems such as monocytes and endothelial cells. However, little attention has been paid, so far, to alterations in the musculoskeletal system, which may contribute to the decline of the general state of health of diabetic people and may limit the therapeutic use of exercise in these subjects.
Diabetes causes non-enzymatic glycation of soft tissues, including muscle and tendon, leading to an increase in muscle and tendon stiffness. It was observed that Achilles tendon stiffness and skin connective tissue cross-linking are greater in diabetic patients compared to controls and it has been suggested that the elevated tendon stiffness may influence gait parameters. Indeed, during walking, diabetic patients display less Achilles tendon elongation, higher tendon stiffness and higher tendon hysteresis compared to healthy controls. The higher energy cost of walking in diabetic patients could thus be related to an impairment of the Achilles tendon function. The stiffening of the muscle, on the other hand, reduces its capability to change in shape, affecting its potential for modulating the mechanical request during contraction (and locomotion), also increasing the metabolic demands. Therefore, investigating the mechanical alterations caused by an increase in muscle and tendon stiffness could provide new insights into diabetes pathophysiology.
Training strategies able to reduce muscle and tendon stiffness are expected to improve muscle-tendon function and locomotor capability of diabetic patients. Even if strength and endurance training protocols allow to improve both blood glucose and muscle contractile function, they seem ineffective in reducing muscle and tendon stiffness in T2D patients. Notably, these training modalities present a significant dropout in the diabetic population, generally higher than 25%.
Static and dynamic stretching are effective in decreasing muscle and tendon stiffness but, in both cases, the decrease in stiffness is associated with a temporary decrease in muscle and tendon mechanical function.
Recently, a new stretching modality (minute oscillation stretching, MOS) was proposed that allows to condition the plantar-flexors muscle-tendon units by providing repetitive small longitudinal length changes using a passive stretch of the ankle joint. In young and healthy participants, a single session of unilateral MOS was sufficient to reduce muscle and tendon stiffness without affecting the muscle strength of the tested leg. Since the plantar-flexor muscles are the most important propulsive muscles for human locomotion, it can be expected that MOS training for the plantar-flexor may improve locomotor capability in diabetic people too. It is noteworthy that, due to the current SARS-Covid-19 pandemic, this training modality can be easily performed at home, under telemedicine training supervision, since no specific equipment is needed.
To summarize, a better understanding of the altered muscle and tendon mechanical properties in TD2 patients and of the effects that these alterations have on muscle contraction and locomotion capability can help in furthering our understanding on how diabetes affects physical activity, leading to inactivity. Finally, to investigate if and how these alterations could be reduced using a simple training program (MOS training), can help in designing more effective interventions, allowing to prescribe training modalities that these patients can easily perform (possibly limiting dropout).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Training (minute oscillation stretching)
- Keywords
- Type 2 Diabetes Mellitus, Muscle and tendon disorders, locomotion capacity, passive stretching
- Medical subject headings
- Diabetes Mellitus, Type 2, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training (minute oscillation stretching)Other
Also called Telemedicine training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon Stiffness Differences Between T2D Patients and Controls
Achilles tendon stiffness (units: Nm/mm) was evaluated during isometric maximum voluntary contractions. In turn, stiffness was calculated based on the ratio between Torque values (units: Nm), which were recorded using a dynamometer (Cybex Norm), and tendon elongation values (units: mm), which were recorded using an ultrasound scanner (MycrusExt, Telemed).
Measured: Data were collected at baseline (pre-intervention)
Secondary outcomes (3)
Effect of Training on Tendon Stiffness (in Patients)
Achilles tendon stiffness (units: Nm/mm) were calculated as described in outcome 1 in diabetic patients.
Changes in these variables were calculated between baseline and post training.
Measured: Data were collected at baseline and immediately after the intervention (10 weeks of training).
Tissue Glycation Indicators (Hb1Ac) in T2D Patients and Controls
Glycated hemoglobin was assessed in blood samples as a measure of long-term glycation.
Measured: Data were collected at baseline (pre-intervention)
Tissue Glycation Indicators (RAGE) in T2D Patients and Controls
RAGE were assessed in skin biopsies as a measure of long-term glycation.
Measured: Data were collected at baseline (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start10 Dec 2022
- Primary completion30 Oct 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, University of Padova
- Responsible party
- Principal investigator, Paola Zamparo, Universita di Verona
- Investigators
- Paola Zamparo, PhD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585502
- Sponsor's protocol ID
- PZamparo
- Acronym
- T2D_MTU
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2022
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lapolla A, Traldi P, Fedele D. AGE in micro- and macroangiopathy. Contrib Nephrol. 2001;(131):10-21. doi: 10.1159/000060063. No abstract available.
PubMed 11125555Sell 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.
PubMed 1397702Martinelli 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.
PubMed 23274122Couppe 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.
PubMed 26542519Petrovic 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.
PubMed 28578139Petrovic 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.
PubMed 29420151Colberg 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.
PubMed 21115758Colberg 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.
PubMed 28265261Ikeda 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.
PubMed 30787652Ikeda 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.
PubMed 32969540Magris R, Monte A, Vigolo N, Nardello F, Trinchi M, Negri C, Gisondi P, Cosma C, Sartore G, Lapolla A, Moghetti P, Zamparo P. Impact of controlled type 2 diabetes on muscle-tendon mechanics. Acta Diabetol. 2026 Jul;63(7):1239-1246. doi: 10.1007/s00592-026-02705-5. Epub 2026 May 6.
PubMed 42089958
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Muscle and Tendon Dysfunction on the Mechanics of Muscle Contraction and Locomotion Capacity in People With Type 2 Diabetes Mellitus, and Efficacy of a Passive Stretching Training Program to Counteract These Alterations
- ClinicalTrials.gov ID
- NCT05585502
- Acronym / sponsor ID
- T2D_MTU / PZamparo
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Muscle and tendon disorders, locomotion capacity, passive stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, University of Padova
- Study start
- 10 Dec 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). According to the International Diabetes Federation (IDF, 2017), 425 million people suffer from diabetes worldwide and these may rise to 629 million in 2045 . Within this epidemiological perspective, diabetes emerges as one of the main metabolic disorders with substantial costs for regional and national sanitary systems.
Diabetes hurts cardiovascular function due to chronic hyperinsulinemia and hyperglycemia, along with increased advanced glycation end products (AGEs), pro-inflammatory cytokines, oxidative stress, obesity, dyslipidemia, and physical inactivity, all of which contribute to vascular dysfunction. In particular, several studies have shown that AGEs exert their negative effects through binding to a specific cellular receptor (RAGE), found in several cell systems such as monocytes and endothelial cells. However, little attention has been paid, so far, to alterations in the musculoskeletal system, which may contribute to the decline of the general state of health of diabetic people and may limit the therapeutic use of exercise in these subjects.
Diabetes causes non-enzymatic glycation of soft tissues, including muscle and tendon, leading to an increase in muscle and tendon stiffness. It was observed that Achilles tendon stiffness and skin connective tissue cross-linking are greater in diabetic patients compared to controls and it has been suggested that the elevated tendon stiffness may influence gait parameters. Indeed, during walking, diabetic patients display less Achilles tendon elongation, higher tendon stiffness and higher tendon hysteresis compared to healthy controls. The higher energy cost of walking in diabetic patients could thus be related to an impairment of the Achilles tendon function. The stiffening of the muscle, on the other hand, reduces its capability to change in shape, affecting its potential for modulating the mechanical request during contraction (and locomotion), also increasing the metabolic demands. Therefore, investigating the mechanical alterations caused by an increase in muscle and tendon stiffness could provide new insights into diabetes pathophysiology.
Training strategies able to reduce muscle and tendon stiffness are expected to improve muscle-tendon function and locomotor capability of diabetic patients. Even if strength and endurance training protocols allow to improve both blood glucose and muscle contractile function, they seem ineffective in reducing muscle and tendon stiffness in T2D patients. Notably, these training modalities present a significant dropout in the diabetic population, generally higher than 25%.
Static and dynamic stretching are effective in decreasing muscle and tendon stiffness but, in both cases, the decrease in stiffness is associated with a temporary decrease in muscle and tendon mechanical function.
Recently, a new stretching modality (minute oscillation stretching, MOS) was proposed that allows to condition the plantar-flexors muscle-tendon units by providing repetitive small longitudinal length changes using a passive stretch of the ankle joint. In young and healthy participants, a single session of unilateral MOS was sufficient to reduce muscle and tendon stiffness without affecting the muscle strength of the tested leg. Since the plantar-flexor muscles are the most important propulsive muscles for human locomotion, it can be expected that MOS training for the plantar-flexor may improve locomotor capability in diabetic people too. It is noteworthy that, due to the current SARS-Covid-19 pandemic, this training modality can be easily performed at home, under telemedicine training supervision, since no specific equipment is needed.
To summarize, a better understanding of the altered muscle and tendon mechanical properties in TD2 patients and of the effects that these alterations have on muscle contraction and locomotion capability can help in furthering our understanding on how diabetes affects physical activity, leading to inactivity. Finally, to investigate if and how these alterations could be reduced using a simple training program (MOS training), can help in designing more effective interventions, allowing to prescribe training modalities that these patients can easily perform (possibly limiting dropout).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Training (minute oscillation stretching)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. |
| 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- neuropathy of nondiabetic origin
- severe neuropathy
- foot ulcers
- arterial insufficiency
- arthritis of the ankle/foot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training (minute oscillation stretching)Also: Telemedicine trainingThe 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. | Other | Training group |
Primary outcome
Tendon Stiffness Differences Between T2D Patients and Controls
Time frame: Data were collected at baseline (pre-intervention)
Achilles tendon stiffness (units: Nm/mm) was evaluated during isometric maximum voluntary contractions. In turn, stiffness was calculated based on the ratio between Torque values (units: Nm), which were recorded using a dynamometer (Cybex Norm), and tendon elongation values (units: mm), which were recorded using an ultrasound scanner (MycrusExt, Telemed).
3 secondary outcomes
Effect of Training on Tendon Stiffness (in Patients)
Time frame: Data were collected at baseline and immediately after the intervention (10 weeks of training).
Tissue Glycation Indicators (Hb1Ac) in T2D Patients and Controls
Time frame: Data were collected at baseline (pre-intervention)
Tissue Glycation Indicators (RAGE) in T2D Patients and Controls
Time frame: Data were collected at baseline (pre-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11125555Lapolla A, Traldi P, Fedele D. AGE in micro- and macroangiopathy. Contrib Nephrol. 2001;(131):10-21. doi: 10.1159/000060063. No abstract available.
- Background: PubMed 1397702Sell 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.
- Background: PubMed 23274122Martinelli 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.
- Background: PubMed 26542519Couppe 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.
- Background: PubMed 28578139Petrovic 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.
- Background: PubMed 29420151Petrovic 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.
- Background: PubMed 21115758Colberg 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.
- Background: PubMed 28265261Colberg 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.
- Background: PubMed 30787652Ikeda 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.
- Background: PubMed 32969540Ikeda 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.
- Derived from this study: PubMed 42089958Magris R, Monte A, Vigolo N, Nardello F, Trinchi M, Negri C, Gisondi P, Cosma C, Sartore G, Lapolla A, Moghetti P, Zamparo P. Impact of controlled type 2 diabetes on muscle-tendon mechanics. Acta Diabetol. 2026 Jul;63(7):1239-1246. doi: 10.1007/s00592-026-02705-5. Epub 2026 May 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Zamparo, PhD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training (minute oscillation stretching) in people with Type 2 Diabetes Mellitus, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon Stiffness Differences Between T2D Patients and Controls (time frame: Data were collected at baseline (pre-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05585502, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.