Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

Diabetic Vascular Complications Clinical Trial

Official title:

Glycemic Variability Predicts Endothelial Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083043
• Other study ID #: 06035
• Status: Completed
• Start date: December 2006
• Est. completion date: March 2011

Study information

• Verified date: February 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Angiopathies
• Diabetic Vascular Complications

Locations

Country	Name	City	State
United States	Winthrop University Hospital	Mineola	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (7)

Albertini JP, Valensi P, Lormeau B, Aurousseau MH, Ferrière F, Attali JR, Gattegno L. Elevated concentrations of soluble E-selectin and vascular cell adhesion molecule-1 in NIDDM. Effect of intensive insulin treatment. Diabetes Care. 1998 Jun;21(6):1008-13. — View Citation

Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. — View Citation

Krzyzanowska K, Mittermayer F, Wolzt M, Schernthaner G. Asymmetric dimethylarginine predicts cardiovascular events in patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1834-9. Epub 2007 Apr 24. — View Citation

Lopes-Virella MF, Carter RE, Gilbert GE, Klein RL, Jaffa M, Jenkins AJ, Lyons TJ, Garvey WT, Virella G; Diabetes Control and Complications Trial/Epidemiology of Diabetes Intervention and Complications Cohort Study Group. Risk factors related to inflammation and endothelial dysfunction in the DCCT/EDIC cohort and their relationship with nephropathy and macrovascular complications. Diabetes Care. 2008 Oct;31(10):2006-12. doi: 10.2337/dc08-0659. Epub 2008 Jul 15. — View Citation

Meigs JB, Hu FB, Rifai N, Manson JE. Biomarkers of endothelial dysfunction and risk of type 2 diabetes mellitus. JAMA. 2004 Apr 28;291(16):1978-86. — View Citation

Monnier L, Mas E, Ginet C, Michel F, Villon L, Cristol JP, Colette C. Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes. JAMA. 2006 Apr 12;295(14):1681-7. — View Citation

Schram MT, Chaturvedi N, Schalkwijk C, Giorgino F, Ebeling P, Fuller JH, Stehouwer CD; EURODIAB Prospective Complications Study. Vascular risk factors and markers of endothelial function as determinants of inflammatory markers in type 1 diabetes: the EURODIAB Prospective Complications Study. Diabetes Care. 2003 Jul;26(7):2165-73. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of endothelial dysfunction biomarkers and glycemic variability	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	Metabolic parameters and glycemic variability	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