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Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cindy Bredefeld, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01083043
First received: March 5, 2010
Last updated: January 15, 2013
Last verified: January 2013

March 5, 2010
January 15, 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Metabolic parameters and glycemic variability [ Time Frame: Day 3 of study enrollment ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum samples

Non-Probability Sample

Adult subjects with Type 2 Diabetes Mellitus from an outpatient Endocrinology Practice

Diabetic Vascular Complications
Not Provided
Type 2 Diabetes Mellitus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01083043
06035
No
Cindy Bredefeld, Winthrop University Hospital
Cindy Bredefeld
Not Provided
Principal Investigator: Lawrence E Shapiro, MD Winthrop University Hospital
Winthrop University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP