Achilles Tendon and Balance in Prediabetes

NCT06519396 | Completed

• 1 other identifier: Achilles
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to evaluate the Achilles tendon size and static and dynamic balance, as well as the role of Achilles tendon on balance in prediabetes. A total of 96 patients were divided into three groups: 1)the control group, consisting of patients without diabetes; 2)the prediabetes group; 3)the diabetes mellitus group. Ultrasonographic measurements of Achilles tendon sizes were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance was assessed.The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.

Conditions

PreDiabetes

Keywords

Achilles Tendon; Balance; Prediabetes

Outcome Measures

Primary Outcomes (2)

• ultrasonographic measurement of achilles tendon

  measurements of thickness (anterior-posterior), width (medial-lateral), and area of achilles tendon at the level of the medial malleolus were made

  baseline

• balance measurement

  Static balance measurement were made with Tetrax Device

  baseline

Study Arms (3)

Control

Patients in the control group had FPG\< 100 mg/dl or 75g oral glucose tolerance test: second hour plasma glucose \<140mg/dl and HbA1c values \<5.7%.

Device: ultrasonography evaluation; Device: tetrax device evaluation

Prediabetes

The diagnosis of prediabetes was also confirmed through the patients' medical records. Patients with FPG 100-125 mg/dl or 75g oral glucose tolerance test: second hour plasma glucose 140-199 mg/dl and HbA1c values 5.7-6.4% was included in the prediabetes group.

Device: ultrasonography evaluation; Device: tetrax device evaluation

Diabetes

The diagnosis of Type 2 Diabetes was confirmed through the patients' medical records. Patients with FPG≥ 126mg/dl or 75g oral glucose tolerance test: second hour plasma glucose ≥200mg/dl and HbA1c ≥6.5% were included in the diabetes group.

Device: ultrasonography evaluation; Device: tetrax device evaluation

Interventions

ultrasonography evaluation DEVICE

Ultrasonographic measurements of the Achilles tendon were taken using Samsung Sonoace X7 ultrasound system equipped with an 8-13MHz linear transducer. After assuming a prone position on the examination table, the patients placed their feet against the wall and flexed their ankles to ensure optimal contact between the probe and the tendon. Measurements were taken separately on the right and left sides for each patient. Initially, the probe was positioned perpendicular to the long axis of the tendon for an axial plane assessment, followed by measurements of thickness (anterior-posterior), width (medial-lateral), and area at the level of the medial malleolus. The thickness and width measurements utilized the tendon's major axes, while the area measurements were automatically calculated by the device through continuous tracing of the tendon circumference in the same section

Control; Diabetes; Prediabetes

tetrax device evaluation DEVICE

A Tetrax device was used to assess static balance. The patient was positioned on the platform and subjected to tests in eight different positions. For each position, a test measurement was made for a duration of 32 seconds, for a total of approximately 5 minutes. The normal eyes-open position was taken as the reference. The effects of vision on balance were observed in the eyes-closed position. Balance is dependent on the back of the heels and the lower vertebrae in this position. Conversely, in the eyes-closed position with the head tilted 30 degrees forward, there is a load on the upper vertebrae and neck. Following the measurements, the Tetrax software program was used to calculate the Fall Index and Stability Index

Control; Diabetes; Prediabetes

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional study was conducted with 90 patients who were admitted to a Physical Medicine and Rehabilitation outpatient clinic. The patients were divided into three groups: 1) the control group (patients who were neither prediabetic nor diabetic; 2) the prediabetes group (prediabetic patients); and 3) the Diabetes Mellitus group (patients with Type 2 Diabetes Mellitus).

You may qualify if:

• being between 40 and 65 years old

You may not qualify if:

• extremity amputation
• vitamin B12 deficiency
• Type 1 Diabetes Mellitus
• prior exposure to neurotoxic agents
• peripheral neuropathy for reasons such as chronic kidney failure, liver failure, - hypothyroidism, hereditary and inflammatory peripheral neuropathies, neuromuscular diseases, malignancies
• anti-neuropathic drug usage
• radiculopathy
• nerve trauma or surgery
• vasculitis and autoimmune disorders
• peripheral vascular disease
• pregnancy
• vestibular and cerebellar problems
• history of lower extremity surgery
• presence of medication affecting balance
• history of alcoholism

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Fulya Bakilan

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Fulya Bakilan

  Eskişehir Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Prof.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: July 25, 2024
• Study Start: February 1, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 30, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)