Charlottesville, Virginia 22906

  • Hyperglycemia, Postprandial

Purpose:

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.


Study summary:

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 .


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


Study is Available At:


Original ID:

200216


NCT ID:

NCT04730882


Secondary ID:

KL2TR003016


Study Acronym:

WBH001


Brief Title:

Effect of Postprandial Hyperglycemia on Vasculature in DM1 and Healthy Adults


Official Title:

Effect of Postprandial Hyperglycemia on Vasculature in DM1 and Healthy Adults


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Virginia


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William Horton, MD
Principal Investigator
University of Virginia, Department of Endocrinology
Primary Contact:William B Horton, MD
434-924-1828
WBH2N@hscmail.mcc.virginia.edu
Backup Contact:Lee Hartline, MEd
434-924-5247
lmh9d@virginia.edu

Study Dates

Start Date:April 6, 2021
Completion Date:January 2025
Completion Type:Anticipated
Primary Completion Date:January 2025
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 27, 2021
First Received Date:January 25, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cardiac contrast enhanced ultrasound ( CEU)
Time Frame:baseline and 2 hours after a meal
Safety Issues:False
Description:Measurement of change in myocardial perfusion
Outcome Type:Secondary Outcome
Measure:Pulse Wave Velocity ( PWV)
Time Frame:baseline and 2 hours after a meal
Safety Issues:False
Description:Measurement of change in central artery stiffness
Outcome Type:Secondary Outcome
Measure:Augmentation Index ( AI)
Time Frame:baseline and 2 hours after a meal
Safety Issues:False
Description:Measurement of change in central artery stiffness
Outcome Type:Secondary Outcome
Measure:Flow Mediated Dilation
Time Frame:baseline and 2 hours after a meal
Safety Issues:False
Description:Vascular measure of change in conduit artery stiffness

Study Interventions

Intervention Type:Dietary Supplement
Name:Mixed Meal
Description:the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively
Arm Name:DM1

Study Arms

Study Arm Type:Other
Arm Name:Healthy Control
Description:Healthy subjects 18-35 years of age
Study Arm Type:Other
Arm Name:DM1
Description:DM1 subjects (18-35 yrs) have DM1 based on WHO diagnostic criteria for > 1 year

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Virginia

Samples and Retentions

Study Population: 16 Healthy controls and 16 DM1
Sample Method:Probability Sample

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Data Source: ClinicalTrials.gov

Date Processed: July 28, 2021

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