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

Comparison of Muscle Strength, Functional Exercise Capacity, Physical Activity Level, and Quality of Life Between Insulin-Using and Non-Insulin-Using Patients With Type 2 Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06935396
Enrollment
67
Registered
2025-04-20
Start date
2019-04-15
Completion date
2019-11-20
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes, muscle strength, quality of life

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.

Interventions

None listed

Sponsors

Eastern Mediterranean University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Grip StrengthThis 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 CapacityThis measurement was taken once at baselineFunctional 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
Quality of Life SF-12Measurement was taken once at baselineQuality 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.
Lower Extremity StrengthMeasurement was taken once at baselineLower 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.
Protective Sensory LossMeasurement was taken once at baselinerotective 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 LevelMeasurement was taken once at baselinePhysical 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 (

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026