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

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ClinicalTrials.gov Identifier: NCT04730882
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : October 10, 2022
Sponsor:
Information provided by (Responsible Party):
William Horton, MD, University of Virginia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Hyperglycemia, Postprandial Dietary Supplement: Mixed Meal

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 Design
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Study Type : Observational
Estimated Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
17 Healthy controls and 17 participants with T1D
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730882


Contacts
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Contact: William B Horton, MD 434-924-1828 WBH2N@hscmail.mcc.virginia.edu
Contact: Lee Hartline, MEd 434-924-5247 lmh9d@virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22906
Contact: Zhenqi Liu, MD    434-243-2603    zl3e@virginia.edu   
Contact: Eugene Barrett, MD, PhD    434-924-1175    ejb8x@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: William Horton, MD University of Virginia, Department of Endocrinology
Study Chair: Zhenqi Liu, MD University of Virginia, Department of Endocrinology
More Information
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Publications:

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Responsible Party: William Horton, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT04730882    
Other Study ID Numbers: 200216
KL2TR003016 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases