Clinical trial NCT06935396: Comparison of Physical Function and Quality of Life in Insulin and Non-Insulin Users With Type 2 Diabetes
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
muscle strength
quality of life
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 67
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

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

Primary outcomes:
measure: Grip Strength
timeFrame: This measurement was taken once at the time of study participation to evaluate the baseline strength level in all groups.
measure: Functional Exercise Capacity
timeFrame: This measurement was taken once at baseline
measure: Quality of Life SF-12
timeFrame: Measurement was taken once at baseline
measure: Lower Extremity Strength
timeFrame: Measurement was taken once at baseline
measure: Protective Sensory Loss
timeFrame: Measurement was taken once at baseline
measure: Physical Activity Level
timeFrame: Measurement was taken once at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Eastern Mediterranean University
state: Famagusta
Study officials:
affiliation: Eastern Mediterranean University
name: Ayşen Karaman, MSc
role: PRINCIPAL_INVESTIGATOR
References: