PreDiabetesNCT06519396
Achilles Tendon and Balance in Prediabetes
An observational study of PreDiabetes, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- ultrasonography evaluation and tetrax device evaluation
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- being between 40 and 65 years old
Who cannot join
- 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
Show all 16Show fewer
- 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
- presence of visual impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Achilles Tendon Measurements and Static and Dynamic Balance in Prediabetes
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.
Read the detailed description
Background/Aims: There is a lack of studies that examine balance problems and Achilles tendon thickness in prediabetes, despite their common occurrence in diabetes. 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 prediabetic patients.
Methods: 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 (thickness, width and area) were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance (the Fall Index, Stability Indexes) was assessed using a Tetrax device. The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.
- Conditions
- PreDiabetes
- Being tested
- ultrasonography evaluation, tetrax device evaluation
- Keywords
- Achilles Tendon, Balance, Prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography evaluationDevice
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
tetrax device evaluationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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. Receives: 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. Receives: Device: ultrasonography evaluation; Device: tetrax device evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
balance measurement
Static balance measurement were made with Tetrax Device
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Feb 2023
- Primary completion20 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Armağan, Eskisehir Osmangazi University
- Investigators
- Fulya Bakilan, Study director, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519396
- Sponsor's protocol ID
- Achilles
- Status last verified
- Jul 2024
- First submitted
- 31 May 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Achilles Tendon Measurements and Static and Dynamic Balance in Prediabetes
- ClinicalTrials.gov ID
- NCT06519396
- Acronym / sponsor ID
- Achilles
- Conditions
- PreDiabetes
- Keywords
- Achilles Tendon, Balance, Prediabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Aims: There is a lack of studies that examine balance problems and Achilles tendon thickness in prediabetes, despite their common occurrence in diabetes. 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 prediabetic patients.
Methods: 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 (thickness, width and area) were performed. Dynamic balance was assessed using the Berg Balance Scale, static balance (the Fall Index, Stability Indexes) was assessed using a Tetrax device. The Self-Leeds Assessment of Neuropathic Symptoms and Signs was utilized to identify neuropathic pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: ultrasonography evaluation, Device: tetrax device evaluationPatients 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%. |
| Prediabetes | – | Device: ultrasonography evaluation, Device: tetrax device evaluationThe 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. |
| Diabetes | – | Device: ultrasonography evaluation, Device: tetrax device evaluationThe 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- being between 40 and 65 years old
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| ultrasonography evaluationUltrasonographic 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 | Device | Control, Diabetes, Prediabetes |
| tetrax device evaluationA 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 | Device | Control, Diabetes, Prediabetes |
Primary outcome
ultrasonographic measurement of achilles tendon
Time frame: baseline
measurements of thickness (anterior-posterior), width (medial-lateral), and area of achilles tendon at the level of the medial malleolus were made
balance measurement
Time frame: baseline
Static balance measurement were made with Tetrax Device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- 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.
Fulya Bakilan study director
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 16 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 25 Jul 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ultrasonographic measurement of achilles tendon (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.