Type 1 Diabetes Autonomic and Vascular Function

NCT06786546 | Enrolling By Invitation

• 1 other identifier: STUDY00004548
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes (Juvenile Onset); Type 1 Diabetes; Diabetes, Autoimmune

Keywords

autonomic function; exercise pressor reflex; muscle sympathetic nerve activity; Reactive hyperemia

Outcome Measures

Primary Outcomes (2)

• Vascular Function

  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

  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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 1 Diabetes

You may qualify if:

• Type 1 diabetes or a Healthy control

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for assessing blood glucose, cholesterol, oxidative stress, pro- and anti-inflammatory cytokines

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2025
• First Posted: January 22, 2025
• Study Start: August 7, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)