Status:
COMPLETED
Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Type 1 Diabetes
Hyperglycemia, Postprandial
Eligibility:
All Genders
18-35 years
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 wi...
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 (contras...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
April 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04730882
Start Date
April 6 2021
End Date
October 18 2024
Last Update
March 30 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22906