Clinical trial NCT05904262: Peripheral Protective Sensation in Type 2 Diabetes Mellitus
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Diabetic Neuropathies
Keywords: Diabetic Foot
Diabetic Neuropathies
Type 2 Diabetes Mellitus
Lead sponsor: Istanbul Kent University
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2023-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were followed up with the diagnosis of Diabetes Mellitus at the Internal Medicine Outpatient Clinic of the Eyup Additional Service Building of Bezmialem October Foundation University

Brief summary: The aim of our study was to investigate the effect of sole sensation on peripheral muscle strength, functional capacity, balance and physical activity level in individuals with Type 2 Diabetes Mellitus.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot Sole Sensation Evaluation
timeFrame: 20 minute
Secondary outcomes:
measure: Body mass index
timeFrame: 5 minute
measure: Body Fat
timeFrame: 5 minute
measure: Skeletal muscle mass
timeFrame: 5 minute
measure: Resting metabolism
timeFrame: 5 minute
measure: Balance
timeFrame: 20 minute
measure: International Physical Activity Questionnaire-Short Form (IPAQ)
timeFrame: 3 minute
measure: Muscle strength
timeFrame: 15 minute
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf Unıversty
Study officials:
References: