Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM
This study has been terminated.
(Due to lack of funds to continue this study.)
Information provided by:
Wyckoff Heights Medical Center
First received: March 14, 2011
Last updated: March 18, 2012
Last verified: March 2012
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.
||Observational Model: Ecologic or Community
Time Perspective: Prospective
||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)
Primary Outcome Measures:
- Study the rate of change of HbA1c in normal population with known risk factors of diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
Low risk group
Patients will be stratified based on risk factors significantly contributing to diabetes type 2.
Intermediate risk group
High risk group
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.
- 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)
- 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
- Polycystic ovarian disease
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315808
|Wyckoff Heights Medical Center
|Brooklyn, New York, United States, 11237 |
Wyckoff Heights Medical Center
||Rekha Bhandari, MD
||Wyckoff Heights Medical Center, Brooklyn New York
||Shitij Arora, MD
||Wyckoff Heights Medical Center
No publications provided
||Rekha Bhandari, Wyckoff Heights Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 14, 2011
||March 18, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders