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

NCT06935396 | Completed

• 1 other identifier: DAU-2025-T2D-INS01
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; muscle strength; quality of life

Outcome Measures

Primary Outcomes (6)

• Grip Strength

  Grip strength was measured using a hand-held dynamometer, where participants squeezed the device with maximal force to record the strength

  This measurement was taken once at the time of study participation to evaluate the baseline strength level in all groups.

• Functional Exercise Capacity

  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

  This measurement was taken once at baseline

• Quality of Life SF-12

  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.

  Measurement was taken once at baseline

• Lower Extremity Strength

  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.

  Measurement was taken once at baseline

• Protective Sensory Loss

  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.

  Measurement was taken once at baseline

• Physical Activity Level

  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 (

  Measurement was taken once at baseline

Study Arms (3)

Insulin-Using Type 2 Diabetes

Participants in this group are Type 2 Diabetes patients who are using insulin therapy. No specific drug dosage is administered as part of this study; the group is simply observed based on their existing insulin treatment regimen.

Non-Insulin-Using Type 2 Diabetes

This group consists of patients diagnosed with Type 2 Diabetes who are not using insulin. They may be managing their condition through oral medications or lifestyle changes, but no specific intervention is provided within the scope of this study.

Healthy Controls

This group consists of healthy individuals with no history of Type 2 Diabetes or any other chronic conditions. No medical intervention or treatment is administered, and they serve as a control group for comparison with the diabetic groups.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of individuals diagnosed with Type 2 Diabetes Mellitus (T2DM). Participants will be divided into three groups: Insulin-using T2DM patients. Non-insulin-using T2DM patients. Healthy controls (no history of diabetes or chronic diseases).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, Famagusta, 99450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ayşen Karaman, MSc

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. PT.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 20, 2025
• Study Start: April 15, 2019
• Primary Completion: August 20, 2019
• Study Completion: November 20, 2019
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

TU (1)