Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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It is well known that lowering average blood glucose decreases the risk of diabetic complications involving the small vessels, such as those found in the eyes, nerves and kidney. It is less clear however, if controlling fluctuations in blood glucose will further help to prevent such complications. The purpose of this study is to examine the relationship between extreme fluctuations in glucose and damage to the blood vessel lining.

Detailed Description
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Studies have shown that glycemic variability is associated with oxidative stress which in turn has been correlated with endothelial damage. Further, endothelial damage has been identified as a critical event lending way to the vascular complications seen in many disease states. The specific aim of this study is to investigate the relationship between short-term glycemic variability and biomarkers of endothelial dysfunction while analyzing the influence of different variables and adjusting for covariates. Data obtained from a continuous glucose monitoring system(CGMS), a device that continuously records interstitial glucose for a 72 hour period, is used to calculate glycemic variability. Serology for the determination of endothelial dysfunction biomarkers is obtained on day three. Pearson and Spearman Rank Order correlations are utilized to determine whether there are any significant correlations between measures of glycemic variability and biomarker levels of endothelial dysfunction. Multiple regression analysis would also determine if glycemic variability predicts elevated biomarker levels even after controlling for other variables. Provided the high prevalence of diabetic complications and their staggering socioeconomic costs, it is important to elucidate the relationship between glycemic variability and endothelial dysfunction.

Official Title
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Glycemic Variability Predicts Endothelial Dysfunction

Conditions
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Diabetic Vascular Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects with Type 2 Diabetes Mellitus and glycosylated hemoglobin <8.0% Exclusion Criteria: Age <18 or >65 BMI >35 Pregnant Baseline glycosylated hemoglobin <6.0% or >8.0% Winthrop University Hospital Employee or Staff member Vulnerable subject Uncontrolled hypertension(defined as systolic blood pressure >130 or diastolic blood pressure >80mmHg) Uncontrolled dyslipidemia (defined as LDL >130mg/dL; HDL <30mg/dL or triglycerides >199mg/dL) Current smoker or significant smoke exposure(defined as greater than 2 hours of exposure to second-hand smoke within the preceding 48hrs) Sympathomimetic use within the past week History of cardiovascular disease History of paroxysmal nocturnal hemoglobinuria History of thrombotic thrombocytopenic purpura History of stage II-V Chronic Kidney Disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 Diabetes Mellitus<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of endothelial dysfunction biomarkers and glycemic variability | The following biomarkers are studied: soluble e-selectin, vascular cell adhesion molecule-1, intercellular adhesion molecule-1 and asymmetric dimethylarginine. These analytes are highly correlated to endothelial dysfunction. | Day 3 of study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic parameters and glycemic variability | Blood pressure, body mass index, fasting glucose, highly sensitive CRP, HbA1c, lipid panel, adiponectin level, urine microalbumin/creatinine ratio will be measured and correlated to glycemic variability. | Day 3 of study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic Variability, Endothelial Dysfunction