Clinical trial NCT06842108: Relationship Between Hemodynamic Changes and Cardiopulmonary Fitness in Type 2 Diabetes Mellitus Patients
Official title: Relationship Between Hemodynamic Changes and Cardiopulmonary Fitness in Type 2 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus Type 2 (T2DM)
Keywords: Diabetes Mellitus
Hemodynamic changes
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 162
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus patients

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: hemodynamic changes
timeFrame: Immediately after performing test
measure: Cardiorespiratory fitness
timeFrame: immediately after performing test
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: bahria university Health sciences campus karachi
state: Sindh
Study officials:
References:
citation: 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.