- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01315808
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM
March 18, 2012 updated by: Wyckoff Heights Medical Center
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM: Comparing the Concept of dx/dt With QD Diabetes Prediction Model. D.E.R.M.S Initiative (Doctor Enabled Risk Management System)
The investigators hypothesize that the HbA1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 DM.
There is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of HbA1c (dx/dt).
In such cases, the rate of change of HbA1c may give the physicians lead time needed to implement the Diabetes Prevention Program measures.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
542
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
-
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New York
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Brooklyn, New York, United States, 11237
- Wyckoff Heights Medical Center
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-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.
Description
Inclusion Criteria:
- No self-reported history of diabetes or pre-diabetes defined as per ADA criteria
- Age greater than 18 years
- Scheduled to receive HbA1c in participating clinic
- Able and willing to give legally effective consent
- Able and willing to participate in patient questionnaires(attached)
Exclusion Criteria:
- Previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. Patients on drugs causing hyperglycemia like Oral Steroids will be excluded.
- Baseline HbA1c level above 5.7
- Severe Anemia (defined as Hb less than 8gm/dL)
- Patients with hemoglobinopathies
- Pregnancy
- Polycystic ovarian 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
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Low risk group
Patients will be stratified based on risk factors significantly contributing to diabetes type 2.
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Intermediate risk group
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High risk group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes prediction model based on the rate of change in HbA1c
Time Frame: one year
|
To develop a mathematical model which will predict the onset of type 2 dm based on the rate of change in HbA1c valued leading to development of pre-diabetes
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one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rekha Bhandari, MD, Wyckoff Heights Medical Center, Brooklyn New York
- Principal Investigator: Shitij Arora, MD, Wyckoff Heights Medical Center
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
March 1, 2011
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
September 1, 2012
Study Registration Dates
First Submitted
March 14, 2011
First Submitted That Met QC Criteria
March 14, 2011
First Posted (Estimate)
March 15, 2011
Study Record Updates
Last Update Posted (Estimate)
March 20, 2012
Last Update Submitted That Met QC Criteria
March 18, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- whmc1
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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