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

February 19, 2025 updated by: Seyyada Tahniat Ali, Bahria University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75300
        • Recruiting
        • Bahria University Health Sciences Campus Karachi
        • Contact:
          • Tahniat Ali
          • Phone Number: 03327503308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetes mellitus patients

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient performing any exercise.
  • cardiovascular diseases.
  • Patients with Cerebrovascular diseases.
  • Patients with Peripheral artery diseases.
  • Patients with pulmonary dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controlled type 2 Diabetes Mellitus patients.
The data will be collected after taking consent from patients who will be undergoing ETT.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic changes
Time Frame: Immediately after performing test
it will be assessed through ΔHeart Rate and HRR1
Immediately after performing test
Cardiorespiratory fitness
Time Frame: immediately after performing test
it will be measured from VO2 max.
immediately after performing test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122/24 (St Vincent's Hospital Melbourne Human Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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