Type 2 DiabetesNCT06935396
Comparison of Physical Function and Quality of Life in Insulin and Non-Insulin Users With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Pill or oral medicine
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 20 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eastern Mediterranean University
Mersin, Famagusta, 99450
About this study
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
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.
Read the 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
- Keywords
- type 2 diabetes, muscle strength, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip strength was measured using a hand-held dynamometer, where participants squeezed the device with maximal force to record the strength
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (
Measured: Measurement was taken once at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start15 Apr 2019
- Primary completion20 Aug 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşen Karaman, Eastern Mediterranean University
- Investigators
- Ayşen Karaman, MSc, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935396
- Sponsor's protocol ID
- DAU-2025-T2D-INS01
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been determined whether individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06935396
- Acronym / sponsor ID
- DAU-2025-T2D-INS01
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, muscle strength, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
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.
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.
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 (
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: Undecided. It has not yet been determined whether individual participant data (IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşen Karaman, MSc principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: This measurement was taken once at the time of study participation to evaluate the baseline strength level in all groups.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.