Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

February 4, 2019 updated by: NYU Langone Health

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type 2 Diabetes Mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 3 of study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 3 of study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Lawrence E Shapiro, MD, Winthrop University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Actual)

February 6, 2019

Last Update Submitted That Met QC Criteria

February 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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