Diabetes Mellitus, Type 2NCT07377448
Insulin Use and Respiratory Muscle Strength in Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 2 Treated With Insulin, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
This study compares breathing function, breathing muscle strength, and recovery after a walking test in adults with type 2 diabetes, based on whether they use insulin. People with type 2 diabetes will be evaluated during a single study visit at Izmir Bakircay University. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2 Treated With Insulin
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 31 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 40-70 years with a diagnosis of type 2 diabetes mellitus who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Research and Practice Center and met the eligibility criteria. Participants were categorized as insulin-treated or non-insulin-treated based on current usual care.
Who may be able to join
- Age 40 to 70 years
- Diagnosis of type 2 diabetes mellitus for at least 1 year
- Receiving diabetes treatment (oral antidiabetic agents and/or insulin) for at least 6 months
- Stable metabolic status (HbA1c ≤ 10%)
- Independent ambulation
- Able to read and understand Turkish
- Provided written informed consent
Who cannot join
- Diagnosis of type 1 diabetes mellitus
- Active diabetic foot ulcer
- Acute respiratory tract infection or known chronic respiratory disease (e.g., COPD, asthma, interstitial lung disease)
- Cardiovascular disease history that may limit exercise testing (e.g., heart failure, uncontrolled hypertension, arrhythmia)
- Neurological disease, musculoskeletal problem, or balance disorder precluding participation in the exercise test
- Major surgery within the past 6 months
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- Current cancer treatment or history of malignancy
- Cognitive impairment or psychiatric condition limiting cooperation
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Muscle Strength, Pulmonary Function, and Post-Exercise Recovery Responses According to Insulin Use in Individuals With Type 2 Diabetes Mellitus
This study compares breathing function, breathing muscle strength, and recovery after a walking test in adults with type 2 diabetes, based on whether they use insulin.
People with type 2 diabetes will be evaluated during a single study visit at Izmir Bakircay University. Participants will be grouped as either currently using insulin or not using insulin as part of their usual diabetes treatment. All participants will complete the same tests: a breathing test (spirometry), breathing muscle strength tests (maximal inspiratory and expiratory pressures), and a 6-minute walk test.
Before the walk test, immediately after the test, and 5 minutes after the test, recovery measures such as heart rate, oxygen saturation, blood pressure, and perceived shortness of breath and fatigue will be recorded. The goal is to understand whether insulin use is associated with differences in breathing and recovery responses in people with type 2 diabetes.
- Keywords
- Insulin Therapy, Respiratory Muscle Strength, Maximal Inspiratory Pressure, Maximal Expiratory Pressure, Spirometry
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
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-Treated Type 2 Diabetes Mellitus | Participants with type 2 diabetes mellitus who are currently using insulin therapy as part of usual care at the time of assessment. | |
| Non-Insulin-Treated Type 2 Diabetes Mellitus | Participants with type 2 diabetes mellitus who are not using insulin therapy as part of usual care at the time of assessment (e.g., lifestyle and/or oral antidiabetic agents). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure (MIP)
Maximal inspiratory pressure (cmH2O) assessed using a respiratory pressure meter according to standardized respiratory muscle strength testing procedures. The best value from repeated acceptable maneuvers will be used for analysis.
Measured: Single Visit (Baseline)
Secondary outcomes (10)
Maximal Expiratory Pressure (MEP)
Maximal expiratory pressure (cmH2O) assessed using a respiratory pressure meter. The best value from repeated acceptable maneuvers will be used.
Measured: single Visit (Baseline)
Spirometry Parameters (FVC) Forced Vital Capacity
Pulmonary function measured by spirometry following standard procedures.
Measured: Single Visit (Baseline)
6-Minute Walk Distance (6MWD)
Total distance walked in 6 minutes (meters) on a standardized 30-meter corridor using standardized instructions.
Measured: Single Visit (During 6-Minute Walk Test)
Heart Rate Response and Recovery After the 6-Minute Walk Test
Heart rate (beats/min) recorded at the specified time points using pulse oximetry.
Measured: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Oxygen Saturation (SpO₂) Response and Recovery After the 6-Minute Walk Test
Peripheral oxygen saturation (SpO₂, %) recorded at the specified time points using pulse oximetry.
Measured: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Blood Pressure Response and Recovery After the 6-Minute Walk Test
Systolic and diastolic blood pressure (mmHg) measured in a seated position at the specified time points.
Measured: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function measured by spirometry following standard procedures.
Measured: Single Visit (Baseline)
FEV1/FVC Ratio
Calculated from spirometry values following standard procedures.
Measured: Single Visit (Baseline)
Peak Expiratory Flow (PEF)
Pulmonary function measured by spirometry following standard procedures.
Measured: Single Visit (Baseline)
Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10)
Perceived dyspnea will be assessed using the Modified Borg Dyspnea Scale (0 = no breathlessness at all; 10 = maximal breathlessness). Higher scores indicate worse dyspnea.
Measured: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start2 Jan 2025
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE KAYALI VATANSEVER, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377448
- Sponsor's protocol ID
- 2468
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Strength, Pulmonary Function, and Post-Exercise Recovery Responses According to Insulin Use in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07377448
- Acronym / sponsor ID
- 2468
- Keywords
- Insulin Therapy, Respiratory Muscle Strength, Maximal Inspiratory Pressure, Maximal Expiratory Pressure, Spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jan 2026 (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 study compares breathing function, breathing muscle strength, and recovery after a walking test in adults with type 2 diabetes, based on whether they use insulin.
People with type 2 diabetes will be evaluated during a single study visit at Izmir Bakircay University. Participants will be grouped as either currently using insulin or not using insulin as part of their usual diabetes treatment. All participants will complete the same tests: a breathing test (spirometry), breathing muscle strength tests (maximal inspiratory and expiratory pressures), and a 6-minute walk test.
Before the walk test, immediately after the test, and 5 minutes after the test, recovery measures such as heart rate, oxygen saturation, blood pressure, and perceived shortness of breath and fatigue will be recorded. The goal is to understand whether insulin use is associated with differences in breathing and recovery responses in people with type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin-Treated Type 2 Diabetes Mellitus | – | –Participants with type 2 diabetes mellitus who are currently using insulin therapy as part of usual care at the time of assessment. |
| Non-Insulin-Treated Type 2 Diabetes Mellitus | – | –Participants with type 2 diabetes mellitus who are not using insulin therapy as part of usual care at the time of assessment (e.g., lifestyle and/or oral antidiabetic agents). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40-70 years with a diagnosis of type 2 diabetes mellitus who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Research and Practice Center and met the eligibility criteria. Participants were categorized as insulin-treated or non-insulin-treated based on current usual care.
Key inclusion criteria (7 listed)
- Age 40 to 70 years
- Diagnosis of type 2 diabetes mellitus for at least 1 year
- Receiving diabetes treatment (oral antidiabetic agents and/or insulin) for at least 6 months
- Stable metabolic status (HbA1c ≤ 10%)
- Independent ambulation
Key exclusion criteria (9 listed)
- Diagnosis of type 1 diabetes mellitus
- Active diabetic foot ulcer
- Acute respiratory tract infection or known chronic respiratory disease (e.g., COPD, asthma, interstitial lung disease)
- Cardiovascular disease history that may limit exercise testing (e.g., heart failure, uncontrolled hypertension, arrhythmia)
- Neurological disease, musculoskeletal problem, or balance disorder precluding participation in the exercise test
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
Maximal Inspiratory Pressure (MIP)
Time frame: Single Visit (Baseline)
Maximal inspiratory pressure (cmH2O) assessed using a respiratory pressure meter according to standardized respiratory muscle strength testing procedures. The best value from repeated acceptable maneuvers will be used for analysis.
10 secondary outcomes
Maximal Expiratory Pressure (MEP)
Time frame: single Visit (Baseline)
Spirometry Parameters (FVC) Forced Vital Capacity
Time frame: Single Visit (Baseline)
6-Minute Walk Distance (6MWD)
Time frame: Single Visit (During 6-Minute Walk Test)
Heart Rate Response and Recovery After the 6-Minute Walk Test
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Oxygen Saturation (SpO₂) Response and Recovery After the 6-Minute Walk Test
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Blood Pressure Response and Recovery After the 6-Minute Walk Test
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Single Visit (Baseline)
FEV1/FVC Ratio
Time frame: Single Visit (Baseline)
Peak Expiratory Flow (PEF)
Time frame: Single Visit (Baseline)
Rating of Perceived Dyspnea During Recovery (Modified Borg Dyspnea Scale, 0-10)
Time frame: Pre-Test; Immediately Post-Test; 5 Minutes Post-Test
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 30 Jan 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 2 Treated With Insulin, run by Izmir Bakircay 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 7 inclusion and 9 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 30 Jan 2026. 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?
Maximal Inspiratory Pressure (MIP) (time frame: Single Visit (Baseline)). 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 30 Jan 2026.