Study Stopped
Due to lack of funds to continue this study.
Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM
1 other identifier
observational
542
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedMarch 20, 2012
March 1, 2012
1.3 years
March 14, 2011
March 18, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
one year
Secondary Outcomes (1)
Diabetes prediction model based on the rate of change in HbA1c
one year
Study Arms (3)
Low risk group
Patients will be stratified based on risk factors significantly contributing to diabetes type 2.
Intermediate risk group
High risk group
Eligibility Criteria
We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wyckoff Heights Medical Center
Brooklyn, New York, 11237, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rekha Bhandari, MD
Wyckoff Heights Medical Center, Brooklyn New York
- PRINCIPAL INVESTIGATOR
Shitij Arora, MD
Wyckoff Heights Medical Center
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 15, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2012
Study Completion
September 1, 2012
Last Updated
March 20, 2012
Record last verified: 2012-03