Comparison of Physical Function and Quality of Life in Insulin and Non-Insulin Users With Type 2 Diabetes

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT06935396
• Lead Sponsor: Eastern Mediterranean University

Brief Summary

This clinical trial aims to compare the muscle strength, functional exercise capacity, physical activity levels, and quality of life between insulin-using and non-insulin-using patients with Type 2 diabetes. The study will involve participants aged 40-70, diagnosed with Type 2 diabetes, and will assess their physical performance through a series of standardized tests. The primary objective is to determine if insulin use impacts the physical fitness and overall health of patients with Type 2 diabetes. Results from this study could lead to better management strategies for diabetic patients.

Detailed Description

This study aims to analyzemuscle strength, functional exercise capacity, physical activity levels, and quality of life (QoL) among a control group, insulin-using, and non-insulin-using patients with Type 2 Diabetes Mellitus. A total of 67 individuals with a mean age of 54.68 ± 7.41 years were included in the study. Among these participants, 18 were insulin users (Group 1), 21 were non-insulin users (Group 2) with Type II Diabetes, and 28 were healthy individuals (Group 3). Demographic data of the participants were recorded. Grip strength was measured using a hand-grip dynamometer, and quadriceps strength was measured with a handheld dynamometer. Functional exercise capacity was evaluated using the 6-minute walk test (6 MWT), and physical activity levels were assessed using the International Physical Activity Questionnaire (IPAQ). The Short Form-12 questionnaire was used to assess QoL, the 30-second sit-to-stand test was used for lower extremity strength, and the Semmes-Weinstein Monofilament test was conducted to evaluate protective sensory loss.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2019-08-20
• Study Completion: 2019-11-20
• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-20
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Must have been diagnosed with Type 2 Diabetes Mellitus by a specialist doctor at least 5 years ago
• Must be between 40-65 years of age
• Must have signed the informed consent form
• Must be literate

Exclusion Criteria

• Presence of active diabetic foot ulcer
• History of acute trauma affecting the musculoskeletal system within the last month
• Presence of musculoskeletal, orthopedic, neurological, or cardiopulmonary diseases
• Participants who are unable to cooperate to the extent that they cannot understand the given instructions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grip Strength	This measurement was taken once at the time of study participation to evaluate the baseline strength level in all groups.	Grip strength was measured using a hand-held dynamometer, where participants squeezed the device with maximal force to record the strength
Functional Exercise Capacity	This measurement was taken once at baseline	Functional exercise capacity was assessed using the 6-minute walk test (6MWT). Participants walked as far as possible in 6 minutes, and the total distance walked was recorded
Lower Extremity Strength	Measurement was taken once at baseline	Lower extremity strength was assessed using the 30-second sit-and-stand test. Participants were asked to rise from a seated position and sit back down repeatedly within 30 seconds, and the total number of repetitions was recorded.
Quality of Life SF-12	Measurement was taken once at baseline	Quality of life was assessed using the Short Form-12 (SF-12) questionnaire. This questionnaire evaluates general health, physical functioning, and mental well-being. It consists of 12 questions selected from the Short Form - 36 (SF-36) quality of life questionnaire. The SF-12 includes the following subcomponents: physical functioning, physical role, pain, general health, emotional role, mental health, social functioning, and vitality.; A Physical Component Summary Score (PCS), which represents the physical domain of quality of life, was calculated from the subcomponents of physical functioning, physical role, general health, and pain.; A Mental Component Summary Score (MCS) was calculated from the subcomponents of emotional role, mental health, vitality, and social functioning.; Each subcomponent and summary score ranges from 0 to 100, with higher scores indicating better quality of life.
Protective Sensory Loss	Measurement was taken once at baseline	rotective sensory loss was assessed using the Semmes-Weinstein Monofilament Test. This test is used to assess the sensation of touch in the feet, particularly for loss of protective sensation.
Physical Activity Level	Measurement was taken once at baseline	Physical activity level was assessed using the International Physical Activity Questionnaire (IPAQ).The International Physical Activity Questionnaire Short Form (IPAQ-SF) will be used to determine the level of physical activity. The Turkish validity and reliability study has been conducted, and the test-retest reliability was found to be r = 0.69. This form is self-administered and consists of seven questions covering the "last seven days" to assess the level of physical activity. It provides information about the time spent sitting, walking, and engaging in moderate- and vigorous-intensity activities. A score is calculated by multiplying the minutes, days, and MET value. For the calculation, a MET value of 8 is used for vigorous physical activity, 4 for moderate-intensity activity, and 3.3 for walking. Since the scale is open access, it does not require permission for use (

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇹🇷 Mersin, Famagusta, Turkey