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

Status

Withdrawn

Conditions

Intervention / Treatment

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

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.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Exercise Test

Subscribe