Continuous Glucose Monitoring in Type 2 Diabetes Mellitus

NCT01083043 | Completed

• 1 other identifier: 06035
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Vascular Complications

Keywords

Glycemic Variability; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Metabolic parameters and glycemic variability

  Day 3 of study enrollment

Study Arms (1)

Type 2 Diabetes Mellitus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult subjects with Type 2 Diabetes Mellitus and glycosylated hemoglobin \<8.0%

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (7)

• 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. doi: 10.1001/jama.295.14.1681.

  PMID: 16609090 BACKGROUND

• Brownlee M. The pathobiology of diabetic complications: a unifying mechanism. Diabetes. 2005 Jun;54(6):1615-25. doi: 10.2337/diabetes.54.6.1615. No abstract available.

  PMID: 15919781 BACKGROUND

• 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.

  PMID: 18628568 BACKGROUND

• Albertini JP, Valensi P, Lormeau B, Aurousseau MH, Ferriere 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. doi: 10.2337/diacare.21.6.1008.

  PMID: 9614623 BACKGROUND

• 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. doi: 10.2337/dc07-0019. Epub 2007 Apr 24.

  PMID: 17456842 BACKGROUND

• 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. doi: 10.2337/diacare.26.7.2165.

  PMID: 12832330 BACKGROUND

• 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. doi: 10.1001/jama.291.16.1978.

  PMID: 15113816 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Diabetic Angiopathies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Lawrence E Shapiro, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 9, 2010
• Study Start: December 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (1)