Type 1 Diabetes Autonomic and Vascular Function

September 11, 2025 updated by: Jasdeep Kaur, University of Texas at Austin

Autonomic Control and Vascular Function in Type 1 Diabetes

The goal of this clinical trial is to investigate the autonomic and vascular function in men and women with Type 1 diabetes. The main questions it aims to answer are:

  1. Patients with type 1 diabetes exhibit attenuated vascular function during steady-state exercise
  2. Patients with type 1 diabetes have altered autonomic function at rest and during exercise pressor reflex
  3. Patients with type 1 diabetes have attenuated muscle sympathetic activity

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Elevated blood glucose levels in individuals with type 1 diabetes can result in both microvascular and macrovascular complications. Research conducted by Song et al. revealed that children with type 1 diabetes exhibit abnormal cerebral perfusion. Additionally, autonomic mechanisms are affected in type 1 diabetes, as indicated in an animal study which demonstrated that the exercise pressor reflex is exaggerated in both male and female rats during the early stages of the disease. However, whether this also occurs in human patients with type 1 diabetes remains unknown.

Therefore, in this study we are interested in studying the autonomic control of exercise and vascular function in T1DM humans.

Study Type

Observational

Enrollment (Estimated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Type 1 Diabetes

Description

Inclusion Criteria:

  • Type 1 diabetes or a Healthy control

Exclusion Criteria:

  • BMI > 40kg/m2
  • Cancer with current treatment
  • HIV
  • Smoker cigarettes
  • Are pregnant or breastfeeding

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

Cohorts and Interventions

Group / Cohort
Type 1 Diabetes Group
Men and women diagnosed with Type 1 diabetes
Healthy Control group
Healthy men and women will be recruited, matched to the Type 1 diabetes group for age, sex and weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular Function
Time Frame: Blood flow will be measured at baseline for 5 min in supine position. During exercise, blood flow will be measured continuously for the 3 minutes of handgrip exercise.
Blood flow (ml/min) will be measured using Doppler ultrasound during steady-state dynamic exercise. Vascular conductance (ml/min/mmHg) will be calculated by dividing blood flow with blood pressure (mmHg). This measure will inform us about the vascular function in type 1 diabetic patients.
Blood flow will be measured at baseline for 5 min in supine position. During exercise, blood flow will be measured continuously for the 3 minutes of handgrip exercise.
Autonomic Function
Time Frame: Blood presure will be measured at baseline for 10 minutes and continuously during 2 minutes of isometric handgrip.
Blood pressure (mmHg) will be measured using Finapres at baseline and during activation of exercise pressor reflex. The exercise reflex will be activated by performing 2 minutes of isometric handgrip exercise at 30% and 40% of the maximal grip strength. This will inform us about the autonomic function in type 1 diabetic patients.
Blood presure will be measured at baseline for 10 minutes and continuously during 2 minutes of isometric handgrip.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Dell Medical School at The University of Texas at Austin

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 (Actual)

August 7, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 11, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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