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NCT Number: NCT06935396

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Mediterranean University

Mersin, Famagusta, 99450, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Grip Strength

    Time frame: 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

  2. Functional Exercise Capacity

    Time frame: 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

  3. Quality of Life SF-12

    Time frame: 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.

  4. Lower Extremity Strength

    Time frame: 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.

  5. Protective Sensory Loss

    Time frame: 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.

  6. Physical Activity Level

    Time frame: 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 (

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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