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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
  Purpose

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.


Condition
Diabetic Vascular Complications

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Glycemic Variability Predicts Endothelial Dysfunction

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Serum samples


Enrollment: 28
Study Start Date: December 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 2 Diabetes Mellitus

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083043

Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Cindy Bredefeld
Investigators
Principal Investigator: Lawrence E Shapiro, MD Winthrop University Hospital
  More Information

Publications:

Responsible Party: Cindy Bredefeld, Prinicipal Investigator, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01083043     History of Changes
Other Study ID Numbers: 06035
Study First Received: March 5, 2010
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Glycemic Variability
Endothelial Dysfunction

Additional relevant MeSH terms:
Diabetic Angiopathies
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014