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. Identifier: NCT01083043
Recruitment Status : Completed
First Posted : March 9, 2010
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):
Cindy Bredefeld, Winthrop University Hospital

March 5, 2010
March 9, 2010
January 16, 2013
December 2006
March 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01083043 on Archive Site
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.
Same as current
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Continuous Glucose Monitoring in Type 2 Diabetes Mellitus
Glycemic Variability Predicts Endothelial Dysfunction

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.

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.

Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Serum samples
Non-Probability Sample
Adult subjects with Type 2 Diabetes Mellitus from an outpatient Endocrinology Practice
Diabetic Vascular Complications
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Type 2 Diabetes Mellitus

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Cindy Bredefeld, Winthrop University Hospital
Cindy Bredefeld
Not Provided
Principal Investigator: Lawrence E Shapiro, MD Winthrop University Hospital
Winthrop University Hospital
January 2013