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Completed

NCT Number: NCT04730882

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mixed meal

Dietary Supplement

the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively

Primary outcomes

  1. Myocardial Microvascular Perfusion (measured by contrast-enhanced ultrasound)

    Time frame: baseline and 2 hours after a meal

    Measurement of change in myocardial microvascular perfusion

Secondary outcomes

  1. 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

  2. Flow Mediated Dilation

    Time frame: baseline and 2 hours after a meal

    Vascular measure of change in conduit artery stiffness

  3. Pulse Wave Velocity ( PWV)

    Time frame: baseline and 2 hours after a meal

    Measurement of change in central artery stiffness

  4. 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

  5. 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

  6. 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

  7. Intercellular Adhesion Molecule 1 (ICAM-1)

    Time frame: baseline and 2 hours after a meal

    Biomarker (plasma sample) of endothelial dysfunction

  8. E-selectin

    Time frame: baseline and 2 hours after a meal

    Biomarker (plasma sample) of endothelial dysfunction

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Acronym: WBH001

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2021
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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