Relationship Between Hemodynamic Changes and Cardiopulmonary Fitness in Type 2 Diabetes Mellitus Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-50
SponsorBahria University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient performing any exercise.

cardiovascular diseases.

Patients with Cerebrovascular diseases.

Patients with Peripheral artery diseases.

Trial population

Type 2 diabetes mellitus patients

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Exercise tolerance test

    Other intervention

    • 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

Treatment groups

162 Participants
are divided into 1 treatment group
Group A: Controlled type 2 Diabetes Mellitus patients.1 intervention

Trial outcomes

Primary outcomes

1

hemodynamic changes

it will be assessed through ΔHeart Rate and HRR1

Time frame
Immediately after performing test
2

Cardiorespiratory fitness

it will be measured from VO2 max.

Time frame
immediately after performing test

Secondary outcomes

Other outcomes

Sponsors and contacts

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