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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR003016 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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 (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).
T1D participants will have 2 study admissions:
A) injection of insulin 15 minutes before ingesting a mixed meal. B) injection of insulin 15 min after ingesting a mixed meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control | Healthy subjects 18-35 years of age |
| |
| Type 1 Diabetes | People with type 1 diabetes (18-35 yrs) who have type 1 diabetes based on WHO diagnostic criteria for > 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed Meal | Dietary Supplement | the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Microvascular Perfusion (measured by contrast-enhanced ultrasound) | Measurement of change in myocardial microvascular perfusion | baseline and 2 hours after a meal |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal Muscle Microvascular Perfusion (measured by contrast-enhanced ultrasound) | Measurement of change in microvascular perfusion of skeletal muscle | baseline and 2 hours after a meal |
| Flow Mediated Dilation |
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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
T1D participants must have T1D based on WHO diagnostic criteria for > 1 year
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.
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17 Healthy controls and 17 participants with T1D
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| Name | Affiliation | Role |
|---|---|---|
| William Horton, MD | University of Virginia, Department of Endocrinology | Principal Investigator |
| Zhenqi Liu, MD | University of Virginia, Department of Endocrinology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25409370 | Background | Lind M, Svensson AM, Kosiborod M, Gudbjornsdottir S, Pivodic A, Wedel H, Dahlqvist S, Clements M, Rosengren A. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014 Nov 20;371(21):1972-82. doi: 10.1056/NEJMoa1408214. | |
| 29127240 | Background | Lee AK, Warren B, Lee CJ, McEvoy JW, Matsushita K, Huang ES, Sharrett AR, Coresh J, Selvin E. The Association of Severe Hypoglycemia With Incident Cardiovascular Events and Mortality in Adults With Type 2 Diabetes. Diabetes Care. 2018 Jan;41(1):104-111. doi: 10.2337/dc17-1669. Epub 2017 Nov 10. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Vascular measure of change in conduit artery stiffness
| baseline and 2 hours after a meal |
| Pulse Wave Velocity ( PWV) | Measurement of change in central artery stiffness | baseline and 2 hours after a meal |
| Tumor Necrosis Factor-Alpha (TNF-alpha) | Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes | baseline and 2 hours after a meal |
| Interleukin 6 (IL-6) | Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes | baseline and 2 hours after a meal |
| high sensitivity C-reactive protein (hsCRP) | Inflammatory biomarker (plasma sample) specific specific to patients with type 1 diabetes | baseline and 2 hours after a meal |
| Intercellular Adhesion Molecule 1 (ICAM-1) | Biomarker (plasma sample) of endothelial dysfunction | baseline and 2 hours after a meal |
| E-selectin | Biomarker (plasma sample) of endothelial dysfunction | baseline and 2 hours after a meal |
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| 31292141 | Background | Tromp J, Lim SL, Tay WT, Teng TK, Chandramouli C, Ouwerkerk W, Wander GS, Sawhney JPS, Yap J, MacDonald MR, Ling LH, Sattar N, McMurray JJV, Richards AM, Anand I, Lam CSP; ASIAN-HF Investigators. Microvascular Disease in Patients With Diabetes With Heart Failure and Reduced Ejection Versus Preserved Ejection Fraction. Diabetes Care. 2019 Sep;42(9):1792-1799. doi: 10.2337/dc18-2515. Epub 2019 Jul 10. |
| 25240451 | Background | Su MY, Lin LY, Tseng YH, Chang CC, Wu CK, Lin JL, Tseng WY. CMR-verified diffuse myocardial fibrosis is associated with diastolic dysfunction in HFpEF. JACC Cardiovasc Imaging. 2014 Oct;7(10):991-7. doi: 10.1016/j.jcmg.2014.04.022. Epub 2014 Sep 17. |
| 22135399 | Background | Ng AC, Auger D, Delgado V, van Elderen SG, Bertini M, Siebelink HM, van der Geest RJ, Bonetti C, van der Velde ET, de Roos A, Smit JW, Leung DY, Bax JJ, Lamb HJ. Association between diffuse myocardial fibrosis by cardiac magnetic resonance contrast-enhanced T(1) mapping and subclinical myocardial dysfunction in diabetic patients: a pilot study. Circ Cardiovasc Imaging. 2012 Jan;5(1):51-9. doi: 10.1161/CIRCIMAGING.111.965608. Epub 2011 Dec 1. |
| 23664053 | Background | Mavrogeni S, Bratis K, Gavra P, Fousteris E, Markussis V, Kolovou G, van Wijk K, Hautemann D, Reiber JH, Melidonis A. Stress cardiac magnetic resonance reveals myocardial perfusion impairment in asymptomatic diabetes mellitus type I, missed by the routine non-invasive evaluation. Int J Cardiol. 2013 Sep 10;167(6):e167-9. doi: 10.1016/j.ijcard.2013.04.170. Epub 2013 May 9. No abstract available. |
| 21947298 | Background | Turkbey EB, Backlund JY, Genuth S, Jain A, Miao C, Cleary PA, Lachin JM, Nathan DM, van der Geest RJ, Soliman EZ, Liu CY, Lima JA, Bluemke DA; DCCT/EDIC Research Group. Myocardial structure, function, and scar in patients with type 1 diabetes mellitus. Circulation. 2011 Oct 18;124(16):1737-46. doi: 10.1161/CIRCULATIONAHA.111.022327. Epub 2011 Sep 26. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |