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NCT Number: NCT06842108

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

bahria university Health sciences campus karachi

Karachi, Sindh, 75300, Pakistan

Location status: Recruiting

Location contact

Tahniat Ali

CONTACT

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.[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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise tolerance test

Other
  • 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

Primary outcomes

  1. hemodynamic changes

    Time frame: Immediately after performing test

    it will be assessed through ΔHeart Rate and HRR1

  2. Cardiorespiratory fitness

    Time frame: immediately after performing test

    it will be measured from VO2 max.

Study contacts

Contact information is provided by the study sponsor or research team.

Tahniat Ali

CONTACT

[email protected]

+923327503308

Sponsors and collaborators

Lead sponsor

Bahria University

Other

Registry information

Acronym: diabetes

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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