Peripheral Protective Sensation in Type 2 Diabetes Mellitus

NCT05904262 | Completed

• 1 other identifier: IstanbulKentU-FTR-MU-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetic Neuropathies

Keywords

Diabetic Foot; Diabetic Neuropathies; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Foot Sole Sensation Evaluation

  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 Outcomes (7)

• Body mass index

  5 minute

• Body Fat

  5 minute

• Skeletal muscle mass

  5 minute

• Resting metabolism

  5 minute

• Balance

  20 minute

Study Arms (1)

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.

Other: Foot Sole Sensation Evaluation

Interventions

Foot Sole Sensation Evaluation 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.

Type 2 diabetic patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Kent University: lead
• Bezmialem Vakif University: collaborator

Study Sites (1)

Bezmialem Vakıf Unıversty

Istanbul, 340060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reserach Assistant

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 15, 2023
• Study Start: June 6, 2023
• Primary Completion: June 25, 2023
• Study Completion: July 25, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)