N2-(1-carboxyethyl)-2'Deoxyguanosine (CEdG) a Potential Biomarker for Diabetes
Evaluation of the Internal Consistency of Measurement and Potential of a DNA-adduct as a Biomarker of Glycemic Control
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to see if the CEdG assay can produce internally consistent results and initiate its validation as a biomarker for diabetes in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Oct 2014
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2019
CompletedNovember 5, 2019
October 1, 2019
4.4 years
January 31, 2014
November 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of quality controls that fall within 15% of the nominal value for a analytical run of the CEdG assay.
One time urine collection
Secondary Outcomes (1)
Correlation of Hemoglobin A1c and CEdG levels
12 months
Study Arms (1)
Diabetes, Non-diabetes
NO INTERVENTIONInterventions
Glucose and its adducts, such as HbA1c, decompose non-enzymatically to yield α-oxo-aldehydes are up to 20,000 x more reactive than the parent molecule. Amounts of an α-oxo-aldehyde, methylglyoxal (MG), are elevated up to 6-fold in patients with Type 1 dm. Quantitation of MG, but MG does form stable, irreversible adducts termed "advanced glycation endproducts" (AGEs) that can be measured. MG also reacts with DNA to yield primarily one stable DNA-AGE, CEdG, and suggests that measuring CEdG might allow for a direct method for assessing glycemic status and α-oxo-aldehyde burden. Investigators have shown that CEdG levels are significantly elevated in urine and tissue of Type 1 \& 2 dm animal models. DNA-AGE may correlate with the development of diabetes complications and identify patients at higher risk. Therefore, the investigators hypothesize that CEdG, a DNA-AGE, can be used as a marker of diabetes control and complications.
Eligibility Criteria
You may qualify if:
- years of age or older
- Registered patient of City of Hope
- Documentation of a diagnosis of diabetes identified by the problem list in the patient's electronic health record
You may not qualify if:
- Current pregnancy
- An active diagnosis of cancer, as CEdG levels may potentially be affected by malignant processes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Termini, PhD
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2014
First Posted
February 19, 2014
Study Start
October 1, 2014
Primary Completion
February 11, 2019
Study Completion
February 11, 2019
Last Updated
November 5, 2019
Record last verified: 2019-10