Type 2 Diabetes Post Exercise Arterial Stiffness

Type 2 Diabetes Clinical Trial

Official title:

Type 2 Diabetes Post Exercise Arterial Stiffness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438874
• Other study ID #: STUDY2024-0610
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Ronald E Jackson, PhD
• Phone: 708-536-0594
• Email: rjacks40[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Exercise Test
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness	Measured via pulse wave velocity	Baseline and up to 20 minutes post exercise
Secondary	Blood pressure	Peak exercise blood pressure	Through exercise test completion, an average of 10 minutes