Glycemic Variability Predicts Endothelial Dysfunction
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| City: |
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Mineola |
| State: |
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New York |
| Zip Code: |
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11501 |
| Conditions: |
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Diabetic Vascular Complications |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT01083043 |
| Primary Contact: |
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Principal Investigator
Lawrence E Shapiro, MD
Winthrop University Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Mineola, New York 11501
United States
Lawrence E Shapiro, MD
Phone: 516-663-3511
Email: lshapiro@winthrop.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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