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OpenTrials
Completed

NCT Number: NCT01083043

Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Winthrop University Hospital

Mineola, New York, 11501, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Glycemic Variability Predicts Endothelial Dysfunction

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2010
Registry last updated
Feb 6, 2019

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.

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