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

NCT ID: NCT06935396

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-11-20

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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Ayşen Karaman

MSc. PT.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşen Karaman, MSc

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University

Locations

Eastern Mediterranean University

Mersin, Famagusta, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DAU-2025-T2D-INS01

Identifier Type: -

Identifier Source: org_study_id