Diabetes Mellitus Type 2 (T2DM)diabetesNCT06842108
Relationship Between Hemodynamic Changes and Cardiopulmonary Fitness in Type 2 Diabetes Mellitus Patients
An observational study of Diabetes Mellitus Type 2 (T2DM), run by Bahria University at 1 site in Pakistan.
Trial summary
Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Diabetes Mellitus Type 2 (T2DM)
- What is being tested?
- Exercise tolerance test
- How many people
- 162 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 15 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Type 2 diabetes mellitus patients
Who may be able to join
- Subjects who agreed to sign the informed consent form.
- Subject with an age group 30-50yrs.
- Female and male.
- Controlled type 2 Diabetes Mellitus patients.
Who cannot join
- Patient performing any exercise.
- cardiovascular diseases.
- Patients with Cerebrovascular diseases.
- Patients with Peripheral artery diseases.
- Patients with pulmonary dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
bahria university Health sciences campus karachi
Karachi, Sindh, 75300
Tahniat Ali, 03327503308
About this study
Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. Cardiorespiratory fitness (CRF) is the capability of our cardiopulmonary system to make oxygen available to our skeletal muscles during physical activities for prolonged time, and is known to be decreased with diabetes. Hemodynamic parameters are correlated with various cardiovascular disorders but little evidence of hemodynamic changes in diabetes patients is present and more studies must be done. This study aims to establish the link between hemodynamic changes and cardiopulmonary fitness in T2DM patients, which could inform clinical practices and interventions to improve management, reduce cardiovascular risks, and enhance the quality of life for these patients.
Read the detailed description
Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction.[1] Diabetes statistics highlight the increasing worldwide impact on individuals, families and nations. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. [2] Cardiorespiratory fitness (CRF) is the capability of our cardiopulmonary system to make oxygen available to our skeletal muscles during physical activities for prolonged time. [3] Diabetes and cardiorespiratory fitness are inter related. According to a 2023 studies on Cardiorespiratory fitness in individuals with T2DM, it was found that T2DM was associated with decreased cardiorespiratory fitness.
Hemodynamic characteristics have been linked to diseases like stroke,, hypertension, and vascular stenosis. Only a few modest studies have investigated the relationship between hemodynamics and diabetes mellitus (DM). The evidence for a link between hemodynamic alterations and CRF in type 2 diabetic individuals needs to be demonstrated. The study aimed to identify the relationship between hemodynamic changes and CRF in type 2 diabetic patients; the findings will help us form inform clinical practices and intervention strategies, ultimately leading to better T2DM management, lowering the risk of cardiovascular complications, and improving T2DM patients' quality of life and longevity.
- Conditions
- Diabetes Mellitus Type 2 (T2DM)
- Being tested
- Exercise tolerance test
- Keywords
- Diabetes Mellitus, Hemodynamic changes
- 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.
Exercise tolerance testOther
- The ETT will be performed using Bruce protocol. The Bruce protocol is a standardized treadmill exercise test used in Exercise Tolerance Testing (ETT) to evaluate cardiovascular fitness and diagnose heart conditions. This protocol is divided into seven stages, each stage duration is 3 minutes and date will be recorded at the end of the each stage. The recorded data will include heart Rate, Rate pressure product (∆RPP), HRR1 and Blood Pressure.
STEP 1:
Patient Preparation
STEP 2:
Consent and history:
STEP 3:
Start of ETT:
- Graded Exercise
STEP 4:
Parameters Recorded During ETT:
- Heart Rate: Monitoring heart rate response to exercise stress.
- Exercise induced changes in heart rate (∆HR) along with change in rate pressure product (∆RPP) due to excercise intensity.
STEP 5:
Cardiopulmonary Fitness Assessment VO2 Max
| Study group | Role | What they receive |
|---|---|---|
| Controlled type 2 Diabetes Mellitus patients. | The data will be collected after taking consent from patients who will be undergoing ETT. Receives: Other: Exercise tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic changes
it will be assessed through ΔHeart Rate and HRR1
Measured: Immediately after performing test
Cardiorespiratory fitness
it will be measured from VO2 max.
Measured: immediately after performing test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Oct 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 (T2DM)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyyada Tahniat Ali, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842108
- Sponsor's protocol ID
- 122/24
- Acronym
- diabetes
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Mhanna SB, Batrakoulis A, Wan Ghazali WS, Mohamed M, Aldayel A, Alhussain MH, Afolabi HA, Wada Y, Gulu M, Elkholi S, Abubakar BD, Rojas-Valverde D. Effects of combined aerobic and resistance training on glycemic control, blood pressure, inflammation, cardiorespiratory fitness and quality of life in patients with type 2 diabetes and overweight/obesity: a systematic review and meta-analysis. PeerJ. 2024 Jun 14;12:e17525. doi: 10.7717/peerj.17525. eCollection 2024.
PubMed 38887616
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Hemodynamic Changes and Cardiopulmonary Fitness in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT06842108
- Acronym / sponsor ID
- diabetes / 122/24
- Conditions
- Diabetes Mellitus Type 2 (T2DM)
- Keywords
- Diabetes Mellitus, Hemodynamic changes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 24 Feb 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.
Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. Cardiorespiratory fitness (CRF) is the capability of our cardiopulmonary system to make oxygen available to our skeletal muscles during physical activities for prolonged time, and is known to be decreased with diabetes. Hemodynamic parameters are correlated with various cardiovascular disorders but little evidence of hemodynamic changes in diabetes patients is present and more studies must be done. This study aims to establish the link between hemodynamic changes and cardiopulmonary fitness in T2DM patients, which could inform clinical practices and interventions to improve management, reduce cardiovascular risks, and enhance the quality of life for these patients.
Detailed description
Diabetes mellitus being metabolic disorder, chronic in nature, is characterized by high levels of glucose in our blood, which often lead to organ dysfunction.[1] Diabetes statistics highlight the increasing worldwide impact on individuals, families and nations. Approximately 10.5 % of adult (20-79 years) have diabetes according to international Diabetes federation. [2] Cardiorespiratory fitness (CRF) is the capability of our cardiopulmonary system to make oxygen available to our skeletal muscles during physical activities for prolonged time. [3] Diabetes and cardiorespiratory fitness are inter related. According to a 2023 studies on Cardiorespiratory fitness in individuals with T2DM, it was found that T2DM was associated with decreased cardiorespiratory fitness.
Hemodynamic characteristics have been linked to diseases like stroke,, hypertension, and vascular stenosis. Only a few modest studies have investigated the relationship between hemodynamics and diabetes mellitus (DM). The evidence for a link between hemodynamic alterations and CRF in type 2 diabetic individuals needs to be demonstrated. The study aimed to identify the relationship between hemodynamic changes and CRF in type 2 diabetic patients; the findings will help us form inform clinical practices and intervention strategies, ultimately leading to better T2DM management, lowering the risk of cardiovascular complications, and improving T2DM patients' quality of life and longevity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled type 2 Diabetes Mellitus patients. | – | Other: Exercise tolerance testThe data will be collected after taking consent from patients who will be undergoing ETT. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Type 2 diabetes mellitus patients
Key inclusion criteria (4 listed)
- Subjects who agreed to sign the informed consent form.
- Subject with an age group 30-50yrs.
- Female and male.
- Controlled type 2 Diabetes Mellitus patients.
Key exclusion criteria (5 listed)
- Patient performing any exercise.
- cardiovascular diseases.
- Patients with Cerebrovascular diseases.
- Patients with Peripheral artery diseases.
- Patients with pulmonary dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise tolerance test• The ETT will be performed using Bruce protocol. The Bruce protocol is a standardized treadmill exercise test used in Exercise Tolerance Testing (ETT) to evaluate cardiovascular fitness and diagnose heart conditions. This protocol is divided into seven stages, each stage duration is 3 minutes and date will be recorded at the end of the each stage. The recorded data will include heart Rate, Rate pressure product (∆RPP), HRR1 and Blood Pressure. STEP 1: Patient Preparation STEP 2: Consent and history: STEP 3: Start of ETT: • Graded Exercise STEP 4: Parameters Recorded During ETT: * Heart Rate: Monitoring heart rate response to exercise stress. * Exercise induced changes in heart rate (∆HR) along with change in rate pressure product (∆RPP) due to excercise intensity. STEP 5: Cardiopulmonary Fitness Assessment VO2 Max | Other | Controlled type 2 Diabetes Mellitus patients. |
Primary outcome
hemodynamic changes
Time frame: Immediately after performing test
it will be assessed through ΔHeart Rate and HRR1
Cardiorespiratory fitness
Time frame: immediately after performing test
it will be measured from VO2 max.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Results publication: PubMed 38887616Al-Mhanna SB, Batrakoulis A, Wan Ghazali WS, Mohamed M, Aldayel A, Alhussain MH, Afolabi HA, Wada Y, Gulu M, Elkholi S, Abubakar BD, Rojas-Valverde D. Effects of combined aerobic and resistance training on glycemic control, blood pressure, inflammation, cardiorespiratory fitness and quality of life in patients with type 2 diabetes and overweight/obesity: a systematic review and meta-analysis. PeerJ. 2024 Jun 14;12:e17525. doi: 10.7717/peerj.17525. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
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 (T2DM), run by Bahria University at 1 site in Pakistan.
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 5 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: looking for participants now, as of the sponsor's last update on 24 Feb 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tahniat Ali (+923327503308, tahniyatali_999@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic changes (time frame: Immediately after performing test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06842108, which also lists 1 linked publication.
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 24 Feb 2025.