Diabetic Vascular ComplicationsNCT01083043
Continuous Glucose Monitoring in Type 2 Diabetes Mellitus
An observational study of Diabetic Vascular Complications, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Vascular Complications
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects with Type 2 Diabetes Mellitus from an outpatient Endocrinology Practice
Who may be able to join
- Adult subjects with Type 2 Diabetes Mellitus and glycosylated hemoglobin <8.0%
Who cannot join
- Age <18 or >65
- BMI >35
- Pregnant
- Baseline glycosylated hemoglobin <6.0% or >8.0%
- Winthrop University Hospital Employee or Staff member
- Vulnerable subject
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Vascular Complications
- Keywords
- Glycemic Variability, Endothelial Dysfunction
- Medical subject headings
- Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Mellitus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 of study enrollment
Secondary outcomes (1)
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.
Measured: Day 3 of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startDec 2006
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Vascular ComplicationsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence E Shapiro, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083043
- Sponsor's protocol ID
- 06035
- Status last verified
- Feb 2019
- First submitted
- 5 Mar 2010
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16609090Brownlee 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.
PubMed 15919781Lopes-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.
PubMed 18628568Albertini 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.
PubMed 9614623Krzyzanowska 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.
PubMed 17456842Schram 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.
PubMed 12832330Meigs 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.
PubMed 15113816
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Variability Predicts Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT01083043
- Acronym / sponsor ID
- 06035
- Conditions
- Diabetic Vascular Complications
- Keywords
- Glycemic Variability, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Mellitus | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with Type 2 Diabetes Mellitus from an outpatient Endocrinology Practice
Key inclusion criteria (1 listed)
- Adult subjects with Type 2 Diabetes Mellitus and glycosylated hemoglobin <8.0%
Key exclusion criteria (14 listed)
- Age <18 or >65
- BMI >35
- Pregnant
- Baseline glycosylated hemoglobin <6.0% or >8.0%
- Winthrop University Hospital Employee or Staff member
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Metabolic parameters and glycemic variability
Time frame: Day 3 of study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Background: PubMed 16609090Monnier 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.
- Background: PubMed 15919781Brownlee 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.
- Background: PubMed 18628568Lopes-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.
- Background: PubMed 9614623Albertini 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.
- Background: PubMed 17456842Krzyzanowska 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.
- Background: PubMed 12832330Schram 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.
- Background: PubMed 15113816Meigs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence E Shapiro, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Vascular Complications, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of endothelial dysfunction biomarkers and glycemic variability (time frame: Day 3 of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01083043, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.