Peripheral Protective Sensation in Type 2 Diabetes Mellitus

NCT ID: NCT05904262

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2023-07-25

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.

Conditions

Diabetic Foot; Diabetic Neuropathies

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Foot Sole Sensation Evaluation

Intervention Type: OTHER

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.

Interventions

Foot Sole Sensation Evaluation

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

Istanbul Kent University

OTHER

Sponsor Role: lead

Responsible Party

Melis Usul

Reserach Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakıf Unıversty

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstanbulKentU-FTR-MU-01

Identifier Type: -

Identifier Source: org_study_id