Continuous Glucose Monitoring in Type 2 Diabetes Mellitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01083043|
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : January 16, 2013
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.
|Condition or disease|
|Diabetic Vascular Complications|
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.
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||Glycemic Variability Predicts Endothelial Dysfunction|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
|Type 2 Diabetes Mellitus|
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083043
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Lawrence E Shapiro, MD||Winthrop University Hospital|