NCT05769712

Brief Summary

The goal of this multi-center, cross-sectional, observational study is to test and compare the difference of the supraspinatus tendon's elasticity between diabetics and healthy people. The main questions it aims to answer are:

  • Ultrasonic characteristics of supraspinatus tendon in diabetic patients
  • Influencing factors of elastic value and thickness of supraspinatus tendon Participants will be asked to:
  • Perform ultrasound examination of the shoulder join.
  • Fill in a survey with certain questions on their basic information.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

March 3, 2023

Last Update Submit

March 3, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

supraspinatus tendonShear wave elastic imagingultrasound

Outcome Measures

Primary Outcomes (1)

  • Elasticity of the supraspinatus tendon

    After activating the SWE mode, the elastic image was generated in the two-amplitude mode. After the image quality mode was qualified (the color curve in the figure was smooth), Shear wave velocity in the superficial and deep layers of the supraspinatus tendon were measured at the distal and proximal ends of the tendon perpendicular to the surface of the humerus, respectively.

    10 mins

Secondary Outcomes (1)

  • Thickness of the supraspinatus tendon

    2 mins

Other Outcomes (1)

  • Blood flow within the supraspinatus tendon

    3 mins

Study Arms (2)

healthy people

Inclusion criteria：① Age range (above 18 years old); ② Non-professional athletes; ③ No medical history of shoulder and neck pain; ④ Ultrasound examination (-). Exclusion criteria: ① pregnant women or postpartum 1 year; ② Shoulder pain with active or passive cervical motion; ③ History of upper extremity trauma; (4) Shoulder surgery or treatment history, intra-articular injection history, use history of glucocorticoids, estrogens, quinolones and cholesterol drugs; (5) Shoulder joint fear test (shoulder joint abduction 90°, slowly increasing external rotation, the subject had a positive expression of fear); (6) Evidence of adhesive shoulder joint bursitis, such as the passive range of motion of the 2 motion planes of the shoulder joint is obviously limited; ⑦ Systemic autoimmune diseases, metabolic diseases, endocrine diseases, psoriasis; ⑧ unable to complete the relevant movements and positions; ⑨ Those who are reluctant to continue the experiment and ask to quit.

Diagnostic Test: Shear wave ultrasonic imaging

diabetic

Inclusion criteria：① Age range (above 18 years old); ② Non-professional athletes; (3) Patients who meet the clinical guidelines for diabetes diagnosis and treatment and are diagnosed with diabetes (ADA guidelines 2020: patients with typical diabetes symptoms and random blood glucose ≥11.1 mmol/L or fasting blood glucose ≥7.0 mmol/L or 2h blood glucose ≥11.1 mmol/L after glucose loading without typical diabetes symptoms); ④ Medical history ≥2 years. Exclusion criteria: as above.

Diagnostic Test: Shear wave ultrasonic imaging

Interventions

Shear wave ultrasonic imagingDIAGNOSTIC_TEST

Shear wave ultrasonic imaging technique was used to measure the superficial and deep shear wave velocity of supraspinatus tendon at 10mm (distal end) and 15mm (proximal end) from the attachment end of the greater tubercle of the humerus on the long axis section of supraspinatus tendon.

diabetichealthy people

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic Inclusion criteria：① Age range (above 18 years old); ② Non-professional athletes; (3) Patients who meet the clinical guidelines for diabetes diagnosis and treatment and are diagnosed with diabetes (ADA guidelines 2020: patients with typical diabetes symptoms and random blood glucose ≥11.1 mmol/L or fasting blood glucose ≥7.0 mmol/L or 2h blood glucose ≥11.1 mmol/L after glucose loading without typical diabetes symptoms); ④ Medical history ≥2 years. Exclusion criteria: as above.

You may qualify if:

  • ① Age range (above 18 years old); ② Non-professional athletes; ③ No medical history of shoulder and neck pain; ④ Ultrasound examination (-).

You may not qualify if:

  • ① pregnant women or postpartum 1 year; ② Shoulder pain with active or passive cervical motion; ③ History of upper extremity trauma; (4) Shoulder surgery or treatment history, intra-articular injection history, use history of glucocorticoids, estrogens, quinolones and cholesterol drugs; (5) Shoulder joint fear test (shoulder joint abduction 90°, slowly increasing external rotation, the subject had a positive expression of fear); (6) Evidence of adhesive shoulder joint bursitis, such as the passive range of motion of the 2 motion planes of the shoulder joint is obviously limited; ⑦ Systemic autoimmune diseases, metabolic diseases, endocrine diseases, psoriasis; ⑧ unable to complete the relevant movements and positions; ⑨ Those who are reluctant to continue the experiment and ask to quit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong second provincial general hospital

Guangzhou, Guangdong, 510317, China

RECRUITING

Related Publications (6)

  • Breda SJ, van der Vlist A, de Vos RJ, Krestin GP, Oei EHG. The association between patellar tendon stiffness measured with shear-wave elastography and patellar tendinopathy-a case-control study. Eur Radiol. 2020 Nov;30(11):5942-5951. doi: 10.1007/s00330-020-06952-0. Epub 2020 Jun 4.

    PMID: 32500197BACKGROUND

  • Abate M, Schiavone C, Salini V. Sonographic evaluation of the shoulder in asymptomatic elderly subjects with diabetes. BMC Musculoskelet Disord. 2010 Dec 7;11:278. doi: 10.1186/1471-2474-11-278.

    PMID: 21138564BACKGROUND

  • Evranos B, Idilman I, Ipek A, Polat SB, Cakir B, Ersoy R. Real-time sonoelastography and ultrasound evaluation of the Achilles tendon in patients with diabetes with or without foot ulcers: a cross sectional study. J Diabetes Complications. 2015 Nov-Dec;29(8):1124-9. doi: 10.1016/j.jdiacomp.2015.08.012. Epub 2015 Aug 20.

    PMID: 26382616BACKGROUND

  • Guney A, Vatansever F, Karaman I, Kafadar IH, Oner M, Turk CY. Biomechanical properties of Achilles tendon in diabetic vs. non-diabetic patients. Exp Clin Endocrinol Diabetes. 2015 Jul;123(7):428-32. doi: 10.1055/s-0035-1549889. Epub 2015 Apr 28.

    PMID: 25918879BACKGROUND

  • Rosskopf AB, Ehrmann C, Buck FM, Gerber C, Fluck M, Pfirrmann CW. Quantitative Shear-Wave US Elastography of the Supraspinatus Muscle: Reliability of the Method and Relation to Tendon Integrity and Muscle Quality. Radiology. 2016 Feb;278(2):465-74. doi: 10.1148/radiol.2015150908. Epub 2015 Nov 5.

    PMID: 26540450BACKGROUND

  • Lin DJ, Burke CJ, Abiri B, Babb JS, Adler RS. Supraspinatus muscle shear wave elastography (SWE): detection of biomechanical differences with varying tendon quality prior to gray-scale morphologic changes. Skeletal Radiol. 2020 May;49(5):731-738. doi: 10.1007/s00256-019-03334-6. Epub 2019 Dec 6.

    PMID: 31811348BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Tong Wang, Master

CONTACT

+86 188636600691013914643@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

March 1, 2021

Primary Completion

November 5, 2023

Study Completion

November 5, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)