Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

NYU Langone Health

Status: Completed

Conditions: Diabetic Vascular Complications

Study type: Observational

Funder types: Other

Identifiers

NCT01083043

06035

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Type 2 Diabetes Mellitus