NCT04730882Completed
Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 36 (actual)
- First submitted
- 25 Jan 2021
- Start date
- 6 Apr 2021
- Primary completion date
- 18 Oct 2024
- Lead sponsor
- University of Virginia
- Diseases
- Type 1 diabetes
- NCT number
- NCT04730882
What you commit to
- Study type: Observational
- Participants enrolled: 36
- From 6 Apr 2021 to the primary completion date, 18 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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
Who the study is looking for
- 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
Age in the registry: 18 years to 35 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.