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

NCT06842108 | Recruiting

• 1 other identifier: 122/24
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2 (T2DM)

Keywords

Diabetes Mellitus; Hemodynamic changes

Outcome Measures

Primary Outcomes (2)

• hemodynamic changes

  it will be assessed through ΔHeart Rate and HRR1

  Immediately after performing test

• Cardiorespiratory fitness

  it will be measured from VO2 max.

  immediately after performing test

Study Arms (1)

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

Interventions

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

Controlled type 2 Diabetes Mellitus patients.

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus patients

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

bahria university Health sciences campus karachi

Karachi, Sindh, 75300, Pakistan

RECRUITING

Related Publications (1)

• 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.

  PMID: 38887616 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Tahniat Ali

CONTACT

+923327503308; tahniyatali_999@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 24, 2025
• Study Start: October 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: April 15, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)