Type 2 Diabetes Post Exercise Arterial Stiffness

NCT06438874 | Withdrawn

• 1 other identifier: STUDY2024-0610
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Arterial stiffness

  Measured via pulse wave velocity

  Baseline and up to 20 minutes post exercise

Secondary Outcomes (1)

• Blood pressure

  Through exercise test completion, an average of 10 minutes

Study Arms (1)

GLP-1 Treatment

EXPERIMENTAL

Individuals diagnosed with type 2 diabetes mellitus (T2DM) who are currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist.

Other: Exercise Test

Interventions

Exercise Test OTHER

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.

GLP-1 Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Diabetes Mellitus; 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

Study Officials

• Ronald E Jackson, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will involve individuals diagnosed with type 2 diabetes mellitus (T2DM) who are currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist compared to a control group of individuals diagnosed with type 2 diabetes mellitus (T2DM) who are receiving treatment with drugs other than glucagon-like peptide 1 (GLP1) agonists. The study will not involve changes to medications for the participants.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 3, 2024
• Study Start: July 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share