- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06438874
Type 2 Diabetes Post Exercise Arterial Stiffness
September 16, 2025 updated by: University of Illinois at Chicago
The overall aim of this research proposal is to determine the impact of GLP1 agonists on post-exercise arterial stiffness.
Therefore, the investigators will examine the cardiovascular responses to exercise in individuals with Type 2 Diabetes mellitus (T2DM) taking these medications during and following a graded maximal exercise test.
Study Overview
Detailed Description
Type 2 diabetes mellitus (T2DM) is a significant public health concern associated with increased cardiovascular morbidity and mortality.
Notably, individuals with T2DM often exhibit increased arterial stiffness, a key indicator of cardiovascular risk.
Pharmacological interventions such as GLP1 agonists have emerged as crucial treatments for T2DM, offering glycemic control and potential cardiovascular benefits, including improvements in blood pressure and arterial stiffness.
However, while the effects of GLP1 agonists on glycemic control and blood pressure regulation have been explored, their impact on arterial stiffness, specifically in response to exercise, remains largely unexplored in individuals with T2DM.
Arterial stiffness is a critical marker of cardiovascular health, and its reduction is associated with decreased cardiovascular risk which include lowered blood pressure.
Therefore, the overall aim of this research is to investigate whether GLP1 agonists attenuate arterial stiffness post exercise and reduce peak exercise blood pressure in individuals with T2DM.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Yes
Description
Inclusion Criteria:
Individuals diagnosed with type 2 diabetes mellitus (T2DM).
- Age between 18 and 60 years old.
- Currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist for the management of T2DM for a minimum duration of six months.
- For control group no current use of a glucagon-like peptide 1 (GLP1) agonist for the management of type 2 diabetes mellitus (T2DM).
- HbA1c levels between 6.5-8%
- Body Mass Index (BMI) within the range of 25 to 40 kg/m2.
Exclusion Criteria:
- Coronary heart disease.
- Pulmonary disease (e.g. asthma, chronic obstructive pulmonary disease)
- Neurological disorders (e.g. Alzheimer's disease, dementia)
- Congestive heart failure.
- Peripheral vascular disease.
- Liver failure.
- Kidney failure.
- Alcohol abuse.
- Drug abuse.
- Smoking.
- Hypertension (defined as Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg)
- Insulin therapy for the management of T2DM
- Severe obesity (defined as Body Mass Index >40 kg/m2);
- Pregnancy
- Non-English speaking individuals
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
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GLP-1 Treatment
Individuals diagnosed with type 2 diabetes mellitus (T2DM) who are currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist.
|
Exercise capacity will be measured as peak oxygen consumption (peakVO2) using an incremental exercise test on a cycle ergometer with an open-circuit spirometry system (TrueOne, Parvo Medics, Sandy, UT) to analyze expired gases.
Exercise testing will follow the American College of Sports Medicine and American Heart Association guidelines.
The investigators will use a graded protocol, starting with a warm-up at 0 watts for 5 minutes, followed by 15 watt increments every 2 minutes until volitional fatigue.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial stiffness
Time Frame: Baseline and up to 20 minutes post exercise
|
Measured via pulse wave velocity
|
Baseline and up to 20 minutes post exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Through exercise test completion, an average of 10 minutes
|
Peak exercise blood pressure
|
Through exercise test completion, an average of 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ronald E Jackson, PhD, University of Illinois Chicago
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 (Estimated)
July 1, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 23, 2024
First Submitted That Met QC Criteria
May 29, 2024
First Posted (Actual)
June 3, 2024
Study Record Updates
Last Update Posted (Actual)
September 22, 2025
Last Update Submitted That Met QC Criteria
September 16, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Respiratory Function Tests
- Ergometry
- Exercise Test
Other Study ID Numbers
- STUDY2024-0610
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
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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