Winthrop University Hospital
Mineola, New York, 11501, United States
NCT Number: NCT01083043
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Mineola, New York, 11501, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
NYU Langone Health
Other
Glycemic Variability Predicts Endothelial Dysfunction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06035536
Cardiovascular Diseases, Chronic Foot Ulcer
Los Angeles, California, United States
View Trial DetailsNCT06035523
Cardiovascular Diseases, Chronic Foot Ulcer
Hollywood, Florida, United States
View Trial DetailsNCT05095922
Cardiovascular Diseases, Diabetes Complications
Nantong, Jiangsu, China
View Trial DetailsNCT05449782
Arterial Stiffness, Cardiovascular Diseases
Guildford, United Kingdom
View Trial Details