ClinicalTrials.gg
Enrolling by invitationNCT06786546Updated Sep 12, 2025

Type 1 Diabetes Autonomic and Vascular Function

An observational study in Type 1 Diabetes (Juvenile Onset), Type 1 Diabetes and Diabetes, Autoimmune, sponsored by University of Texas at Austin. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by University of Texas at Austin · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
72
Ages
18 Years to 70 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

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

Keywords

  • autonomic function
  • exercise pressor reflex
  • muscle sympathetic nerve activity
  • Reactive hyperemia
03

In context

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

This study's planned enrollment of 72 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Type 1 Diabetes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type 1 diabetes or a Healthy control

Exclusion criteria

Exclusion Criteria:

  • > 40kg/m2
  • Cancer with current treatment
  • Smoker cigarettes
  • Are pregnant or breastfeeding
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
72 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    Time frame: Blood presure will be measured at baseline for 10 minutes and continuously during 2 minutes of isometric handgrip.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for Dec 2028, 64 months after the start.

Of 249 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 64 months is above that.

Counting every sponsor, half of 299 studies reached it within 30 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2025
First posted
Jan 22, 2025
StartActual
Aug 7, 2023
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2029
Last update
Sep 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06786546
Responsible party
Jasdeep Kaur (Assistant Professor, University of Texas at Austin) — Principal investigator
First posted
Jan 22, 2025
Start date
Aug 7, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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