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Effect of Postprandial Hyperglycemia on Vasculature in DM1 and Healthy Adults (WBH001)

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ClinicalTrials.gov Identifier: NCT04730882
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
William Horton, MD, University of Virginia

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 DM1. Observational studies using CEU in DM2 subjects 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 DM1 when compared to healthy controls. Furthermore, the investigator hypothesizes in DM1, that dosing insulin before meal intake will ameliorate these cardiovascular defects.

Condition or disease Intervention/treatment
DM1 Hyperglycemia, Postprandial Dietary Supplement: Mixed Meal

Detailed Description:

The investigator will compare 16 DM1 and 16 Healthy control subjects( 18-35 yrs) measuring pulse wave velocity ( PWV), augmentation index ( AI), 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).

DM1 subjects will have 2 study admissions:

A) DM1 subjects will have an injection of insulin 15 minutes before ingesting a mixed meal.

B) DM1 subjects will have an injection of insulin 15 min after ingesting a meal .

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Postprandial Hyperglycemia on Vasculature in DM1 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

MedlinePlus related topics: Hyperglycemia

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

DM1
DM1 subjects (18-35 yrs) have DM1 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




Primary Outcome Measures :
  1. Cardiac contrast enhanced ultrasound ( CEU) [ Time Frame: baseline and 2 hours after a meal ]
    Measurement of change in myocardial perfusion


Secondary Outcome Measures :
  1. Pulse Wave Velocity ( PWV) [ Time Frame: baseline and 2 hours after a meal ]
    Measurement of change in central artery stiffness

  2. Augmentation Index ( AI) [ Time Frame: baseline and 2 hours after a meal ]
    Measurement of change in central artery stiffness

  3. Flow Mediated Dilation [ Time Frame: baseline and 2 hours after a meal ]
    Vascular measure of change in conduit artery stiffness



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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
16 Healthy controls and 16 DM1
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
    • DM1 subjects have DM1 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

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
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: April 28, 2021
Last Verified: April 2021

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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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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases