Trial Outcomes & Findings for Impact of Muscle and Tendon Dysfunction in People With Type 2 Diabetes Mellitus (NCT NCT05585502)
NCT ID: NCT05585502
Last Updated: 2026-07-06
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Data were collected at baseline (pre-intervention)
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Diabetic Patients
Twenty-eight T2D patients were recruited. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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Control Group
Eighteen subjects were recruited as a control group. They were matched for age/sex, BMI and level of physical activity. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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|---|---|---|
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Overall Study
STARTED
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28
|
18
|
|
Overall Study
COMPLETED
|
28
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Diabetic Patients
n=28 Participants
Twenty-eight T2D patients were recruited. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
|
Control Group
n=18 Participants
Eighteen subjects were recruited as a control group. They were matched for age/sex, BMI and level of physical activity. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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Total
n=46 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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62.5 years
STANDARD_DEVIATION 4.5 • n=28 Participants
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63.9 years
STANDARD_DEVIATION 5.3 • n=18 Participants
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63.2 years
STANDARD_DEVIATION 4.9 • n=46 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=28 Participants
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10 Participants
n=18 Participants
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19 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=28 Participants
|
8 Participants
n=18 Participants
|
27 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Italy
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28 participants
n=28 Participants
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18 participants
n=18 Participants
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46 participants
n=46 Participants
|
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BMI (body mass index)
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26.9 kg/m2
STANDARD_DEVIATION 2.5 • n=28 Participants
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25.6 kg/m2
STANDARD_DEVIATION 2.8 • n=18 Participants
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26.2 kg/m2
STANDARD_DEVIATION 2.6 • n=46 Participants
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|
IPAQ (levels of physical activity)
|
1158 MET-min/week
STANDARD_DEVIATION 314 • n=28 Participants
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1597 MET-min/week
STANDARD_DEVIATION 571 • n=18 Participants
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1377 MET-min/week
STANDARD_DEVIATION 442 • n=46 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Diabetic Patients
n=28 Participants
Twenty-eight T2D patients were recruited. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
|
Control Group
n=18 Participants
Eighteen subjects were recruited as a control group. They were matched for age/sex, BMI and level of physical activity. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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|---|---|---|
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Tendon Stiffness Differences Between T2D Patients and Controls
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8.28 Nm/mm
Standard Deviation 2.01
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5.56 Nm/mm
Standard Deviation 1.62
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SECONDARY outcome
Timeframe: Data were collected at baseline and immediately after the intervention (10 weeks of training).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.
Outcome measures
| Measure |
Diabetic Patients
n=17 Participants
Twenty-eight T2D patients were recruited. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
|
Control Group
n=17 Participants
Eighteen subjects were recruited as a control group. They were matched for age/sex, BMI and level of physical activity. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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|---|---|---|
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Effect of Training on Tendon Stiffness (in Patients)
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6.32 Nm/mm
Standard Deviation 3.49
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4.20 Nm/mm
Standard Deviation 3.12
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SECONDARY outcome
Timeframe: Data were collected at baseline (pre-intervention)Glycated hemoglobin was assessed in blood samples as a measure of long-term glycation.
Outcome measures
| Measure |
Diabetic Patients
n=28 Participants
Twenty-eight T2D patients were recruited. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
|
Control Group
n=18 Participants
Eighteen subjects were recruited as a control group. They were matched for age/sex, BMI and level of physical activity. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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|---|---|---|
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Tissue Glycation Indicators (Hb1Ac) in T2D Patients and Controls
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6.9 % of total Hb
Standard Deviation 3.0
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5.5 % of total Hb
Standard Deviation 2.4
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SECONDARY outcome
Timeframe: Data were collected at baseline (pre-intervention)RAGE were assessed in skin biopsies as a measure of long-term glycation.
Outcome measures
| Measure |
Diabetic Patients
n=28 Participants
Twenty-eight T2D patients were recruited. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
|
Control Group
n=18 Participants
Eighteen subjects were recruited as a control group. They were matched for age/sex, BMI and level of physical activity. At baseline they participated to three different experimental sessions: during the first session a blood sample was withdrawn and a skin biopsy was taken; during the second session, muscle-tendon stiffness and muscle function were evaluated; during the third session, the energy cost of walking was determined at different speeds.
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|---|---|---|
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Tissue Glycation Indicators (RAGE) in T2D Patients and Controls
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0.13 ng/mL
Standard Deviation 0.07
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0.11 ng/mL
Standard Deviation 0.14
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Adverse Events
Diabetic Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place