Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults (WBH001)

March 25, 2025 updated by: William Horton, MD, University of Virginia
To the investigator's knowledge, there are no data available in the current literature regarding the acute effects of postprandial hyperglycemia and insulin timing on myocardial perfusion in people with type 1 diabetes (T1D). Observational studies using CEU in type 2 diabetes demonstrate that postprandial hyperglycemia determines myocardial perfusion defects. The investigator hypothesizes that the combination of postprandial hyperglycemia and insulin increases pulse wave velocity (i.e., aortic stiffness) and myocardial vasoconstriction, thereby reducing myocardial perfusion in T1D when compared to healthy controls. Furthermore, the investigator hypothesizes in T1D that dosing insulin before meal intake will ameliorate these cardiovascular defects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigator will compare 17 T1D and 17 age-, sex-, and BMI-matched healthy controls (18-35 yrs) measuring pulse wave velocity (PWV), flow-mediated dilation (FMD) and myocardial perfusion (contrast enhanced ultrasound [CEU]) before and 2 hours after ingesting a mixed meal (40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively).

T1D participants will have 2 study admissions:

A) injection of insulin 15 minutes before ingesting a mixed meal. B) injection of insulin 15 min after ingesting a mixed meal.

Study Type

Observational

Enrollment (Actual)

36

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
    • Virginia
      • Charlottesville, Virginia, United States, 22906
        • University of Virginia

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

17 Healthy controls and 17 participants with T1D

Description

Inclusion Criteria:

  • Healthy with no chronic illness

    • Age 18-35 years
    • BMI ≤ 30 (wt kg/ht m2)
    • Normal screening labs or no clinically significant values

    • T1D participants must have T1D based on WHO diagnostic criteria for > 1 year

      • A fasting plasma glucose level >126 mg/dl (7.0 mmol/l)
      • A casual plasma glucose >200 mg/dl (11.1 mmol/l)
      • In the absence of unequivocal hyperglycemia, the diagnosis must be confirmed on a subsequent day.
    • Subjects using sensor-augmented insulin pump therapy and/or artificial pancreas (closed loop system) will be included

Exclusion Criteria:

  • • Smoking presently or have quit < 2 years.

    • BP >140/90 mmHg
    • BMI >30 (wt kg/ht m2)
    • Pulse oximetry <90%
    • Elevated LDL cholesterol > 160 mg/dl
    • HbA1c ≥ 9 %
    • Use of statins, calcium channel blocker, ACE, ARB, nitrates, alpha-beta blockers or diuretics
    • History of cardiac, cerebrovascular, gastrointestinal, liver, renal decease or cancer
    • Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
    • Retinopathy (beyond mild non proliferative retinopathy)
    • Urine albumin/creatinine ratio > 300 mg per g
    • Pregnant or breastfeeding.
    • Known hypersensitivity to perflutren (contained in Definity

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Control
Healthy subjects 18-35 years of age
Dietary supplement: Mixed Meal
the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively
Type 1 Diabetes
People with type 1 diabetes (18-35 yrs) who have type 1 diabetes based on WHO diagnostic criteria for > 1 year
Dietary supplement: Mixed Meal
the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Microvascular Perfusion (measured by contrast-enhanced ultrasound)
Time Frame: baseline and 2 hours after a meal
Measurement of change in myocardial microvascular perfusion
baseline and 2 hours after a meal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal Muscle Microvascular Perfusion (measured by contrast-enhanced ultrasound)
Time Frame: baseline and 2 hours after a meal
Measurement of change in microvascular perfusion of skeletal muscle
baseline and 2 hours after a meal
Flow Mediated Dilation
Time Frame: baseline and 2 hours after a meal
Vascular measure of change in conduit artery stiffness
baseline and 2 hours after a meal
Pulse Wave Velocity ( PWV)
Time Frame: baseline and 2 hours after a meal
Measurement of change in central artery stiffness
baseline and 2 hours after a meal
Tumor Necrosis Factor-Alpha (TNF-alpha)
Time Frame: baseline and 2 hours after a meal
Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes
baseline and 2 hours after a meal
Interleukin 6 (IL-6)
Time Frame: baseline and 2 hours after a meal
Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes
baseline and 2 hours after a meal
high sensitivity C-reactive protein (hsCRP)
Time Frame: baseline and 2 hours after a meal
Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes
baseline and 2 hours after a meal
Intercellular Adhesion Molecule 1 (ICAM-1)
Time Frame: baseline and 2 hours after a meal
Biomarker (plasma sample) of endothelial dysfunction
baseline and 2 hours after a meal
E-selectin
Time Frame: baseline and 2 hours after a meal
Biomarker (plasma sample) of endothelial dysfunction
baseline and 2 hours after a meal

Collaborators and Investigators

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

Sponsor

University of Virginia

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: William Horton, MD, University of Virginia, Department of Endocrinology
  • Study Chair: Zhenqi Liu, MD, University of Virginia, Department of Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 6, 2021

Primary Completion (Actual)

October 18, 2024

Study Completion (Actual)

October 18, 2024

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200216
  • KL2TR003016 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Mixed Meal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe