- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05904262
Peripheral Protective Sensation in Type 2 Diabetes Mellitus
The Effect of Peripheral Protective Sensation on Peripheral Muscle Strength, Functional Capacity, Balance and Physical Activity Level in Patients With Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Type II diabetes mellitus (DM) is a chronic disease characterised by insulin resistance, which is common all over the world, imposes an economic burden on the patient and his/her family because it requires continuous care and treatment, and may adversely affect the quality and duration of life of patients by leading to organ and function losses due to the complications it causes. Today, diabetes is an increasingly important health problem due to its incidence and the problems it causes. In DM, macrovascular and microvascular complications are observed with the disease. It may lead to development of foot deformities, biomechanical abnormalities and loss of protective sensation in the foot due to motor, sensory and autonomic neuropathy especially in the lower extremity. In the progressive process, loss of protective sensation may result in peripheral neuropathy. In the literature, loss of protective sensation is shown as the primary cause of peripheral neuropathy. In a study, it was found that light touch pressure, two-point discrimination and vibration senses on the soles of the feet of patients with diabetes mellitus decreased compared to healthy individuals. Diabetic foot is an important complication of diabetes which can be prevented with patient education and early treatment, although mortality, morbidity and treatment costs are quite high. This condition affects the individual's life in many aspects. When reseracher examine the literature, most of the studies on physical activity, functional capacity and quality of life in individuals with Type 2 DM with neuropathy examine the effect of neuropathy on these parameters. There is little literature examining the effect of protective sensory loss before the development of neuropathy. Researcher think that it is important to evaluate the sole sensation before the development of neuropathy in type 2 DM patients in order to determine the risk factors. Researcher also think that we will contribute to the literature by examining the relationship between the level of protective sensory loss and muscle strength, functional capacity, balance and physical activity level.
The study is planned to include 30 volunteer participants diagnosed with Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, participants are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Melis USUL, Reserach Assistant
- Phone Number: +90(536)4667235
- Email: melis.usul@kent.edu.tr
Study Contact Backup
- Name: Semiramis Özyılmaz, Assoc. Dr.
- Phone Number: +905337603610
- Email: semiramisozyilmaz@gmail.com
Study Locations
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-
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Istanbul, Turkey, 340060
- Bezmialem Vakıf Unıversty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being diagnosed with Type 2 Diabetes Mellitus for at least 1 year
- To be between the ages of 18-65
- HbA1c value between 6.5-11
- No cognitive/mental problems
- Being able to walk independently
- Being literate in Turkish
Exclusion Criteria:
- Lack of co-operation
- Patients with uncontrolled hypertension and uncontrolled arrhythmias
- Vertigo and various vestibular system disorders
- Those with severe neurological or severe respiratory diseases
- Patients who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker
- Previous stroke, myocardial infarction
- Patients with major musculoskeletal problems
- Chronic renal failure
- Chronic liver disease
- Patients with hip or knee replacement surgery in the last 5 years
- Patients with an injury involving the lower extremity in the last 6 months
- Those who are pregnant
- Those with haemolytic or renal anaemia
- Those who cannot read and write Turkish
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 2 diabetic patients
Type 2 Diabetes Mellitus.
In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®).
In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.
|
Type 2 Diabetes Mellitus.
In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®).
In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Foot Sole Sensation Evaluation
Time Frame: 20 minute
|
Light touch pressure sensation will be assessed with the 10-g monofilament -Semmes Weinstein test.
A 128 Hz diapause will be used to test the sense of vibration.
Firstly, the diaposon will be applied to the patient's wrist (it can be on the elbow or clavicle), so that the patient will know what to experience beforehand.
The diapozone is placed on the bone on the dorsal side of the distal phalanx of the first toe of the foot.For two-point discrimination sensation, two-point discrimination distance measurement with an esthesiometer (Baseline® , White Plains, NY, USA) will be used
|
20 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: 5 minute
|
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.;
Japan)" will be used to measure Body mass index (kg/m2) of the participants.
|
5 minute
|
Body Fat
Time Frame: 5 minute
|
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.;
Japan)" will be used to measure Body fat (%) of the participants.
|
5 minute
|
Skeletal muscle mass
Time Frame: 5 minute
|
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.;
Japan)" will be used to measure skeletal mass (%) of the participants.
|
5 minute
|
Resting metabolism
Time Frame: 5 minute
|
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.;
Japan)" will be used to measure resting metabolism (kcal) of the participants.
|
5 minute
|
Balance
Time Frame: 20 minute
|
Postural stability, stability limits and sensory integration of balance will be evaluated with Biodex Balance System®.
Biodex Balance System® is an equipment used to evaluate postural stability, stability limits and fall risk, and validity and reliability studies have been performed
|
20 minute
|
International Physical Activity Questionnaire-Short Form (IPAQ)
Time Frame: 3 minute
|
The questionnaire includes questions about physical activity performed for at least 10 minutes in the last 7 days.
In the questionnaire, it is determined how many days in the last week and how long each day was spent in heavy physical activity (VPA), moderate physical activity (MPA) and walking (W).
In the last question, the time spent daily without moving is questioned.
|
3 minute
|
Muscle strength
Time Frame: 15 minute
|
The muscle strength of M. Biceps Brachii and M. Quadriceps Femoris will be performed using an electronic hand dynamometer (Commander Muscle Tester; JTECH Medical, USA).
The grip force will be performed from the dominant hand using a Jamar brand dynamometer from hydraulic measuring instruments.
Data obtained will be recorded in kilograms/force (kg/N)
|
15 minute
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Foot Ulcer
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetic Foot
- Diabetic Neuropathies
Other Study ID Numbers
- IstanbulKentU-FTR-MU-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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