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


NCT ID:

NCT04730882


Primary Contact:

Principal Investigator
William Horton, MD
University of Virginia, Department of Endocrinology

William B Horton, MD
Phone: 434-924-1828
Email: WBH2N@hscmail.mcc.virginia.edu


Backup Contact:

Email: lmh9d@virginia.edu
Lee Hartline, MEd
Phone: 434-924-5247


Location Contact:

Charlottesville, Virginia 22906
United States

Zhenqi Liu, MD
Phone: 434-243-2603
Email: zl3e@virginia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

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