Type 1 Diabetes Autonomic and Vascular Function

• Conditions: Type 1 Diabetes (Juvenile Onset); Type 1 Diabetes; Diabetes, Autoimmune

• Registration Number: NCT06786546
• Lead Sponsor: University of Texas at Austin

Brief Summary

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

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 Timeline

• Study Start: 2023-08-07
• Status Verified: 2024-08
• Study First Submitted: 2025-01-11
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular Function	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.
Autonomic Function	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.

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States