Continuous Glucose Monitoring in Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:2/8/2019
Start Date:December 2006
End Date:March 2011

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Glycemic Variability Predicts Endothelial Dysfunction

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.

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.

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
We found this trial at
1
site
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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