Clinical Trial: Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Glycemic Variability Predicts Endothelial Dysfunction

Brief Summary:

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 Summary:

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.


Sponsor: Cindy Bredefeld

Current Primary Outcome: Serum levels of endothelial dysfunction biomarkers and glycemic variability [ Time Frame: Day 3 of study enrollment ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Metabolic parameters and glycemic variability [ Time Frame: Day 3 of study enrollment ]

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.


Original Secondary Outcome: Same as current

Information By: Winthrop University Hospital

Dates:
Date Received: March 5, 2010
Date Started: December 2006
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013