Effect of Postprandial Hyperglycemia on Vasculature in Type 1 Diabetes and Healthy Adults
NCT ID: NCT04730882
Last Updated: 2025-03-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
36 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-04-06
Study Completion Date
2024-10-18
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Type 1 Diabetes
Hyperglycemia, Postprandial
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Healthy Control
Healthy subjects 18-35 years of age
Mixed Meal
Intervention Type
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
Type 1 Diabetes
People with type 1 diabetes (18-35 yrs) who have type 1 diabetes based on WHO diagnostic criteria for \> 1 year
Mixed Meal
Intervention Type
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
Interventions
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Mixed Meal
the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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
* 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 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 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
35 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Sponsor Role
collaborator
University of Virginia
OTHER
Sponsor Role
lead
Responsible Party
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William Horton, MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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William Horton, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia, Department of Endocrinology
Zhenqi Liu, MD
Role: STUDY_CHAIR
University of Virginia, Department of Endocrinology
Locations
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University of Virginia
Charlottesville, Virginia, United States
Site Status
Countries
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United States
References
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Chan A, Barrett EJ, Anderson SM, Kovatchev BP, Breton MD. Muscle microvascular recruitment predicts insulin sensitivity in middle-aged patients with type 1 diabetes mellitus. Diabetologia. 2012 Mar;55(3):729-36. doi: 10.1007/s00125-011-2402-3. Epub 2011 Dec 14.
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Breton MD, Patek SD, Lv D, Schertz E, Robic J, Pinnata J, Kollar L, Barnett C, Wakeman C, Oliveri M, Fabris C, Chernavvsky D, Kovatchev BP, Anderson SM. Continuous Glucose Monitoring and Insulin Informed Advisory System with Automated Titration and Dosing of Insulin Reduces Glucose Variability in Type 1 Diabetes Mellitus. Diabetes Technol Ther. 2018 Aug;20(8):531-540. doi: 10.1089/dia.2018.0079. Epub 2018 Jul 6.
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Monnier L, Colette C, Wojtusciszyn A, Dejager S, Renard E, Molinari N, Owens DR. Toward Defining the Threshold Between Low and High Glucose Variability in Diabetes. Diabetes Care. 2017 Jul;40(7):832-838. doi: 10.2337/dc16-1769. Epub 2016 Dec 30.
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Kovatchev B, Cobelli C. Glucose Variability: Timing, Risk Analysis, and Relationship to Hypoglycemia in Diabetes. Diabetes Care. 2016 Apr;39(4):502-10. doi: 10.2337/dc15-2035.
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Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.
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Ohkuma T, Komorita Y, Peters SAE, Woodward M. Diabetes as a risk factor for heart failure in women and men: a systematic review and meta-analysis of 47 cohorts including 12 million individuals. Diabetologia. 2019 Sep;62(9):1550-1560. doi: 10.1007/s00125-019-4926-x. Epub 2019 Jul 18.
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Lind M, Bounias I, Olsson M, Gudbjornsdottir S, Svensson AM, Rosengren A. Glycaemic control and incidence of heart failure in 20,985 patients with type 1 diabetes: an observational study. Lancet. 2011 Jul 9;378(9786):140-6. doi: 10.1016/S0140-6736(11)60471-6. Epub 2011 Jun 24.
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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.
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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.
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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.
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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.
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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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200216
Identifier Type: -
Identifier Source: org_study_id
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