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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 Identifier:
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.

Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: 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)

Further study details as provided by Wyckoff Heights Medical Center:

Primary Outcome Measures:
  • Study the rate of change of HbA1c in normal population with known risk factors of diabetes [ Time Frame: one year ]

Secondary Outcome Measures:
  • 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

Enrollment: 542
Study Start Date: March 2011
Estimated Study Completion Date: September 2012
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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.

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
  Contacts and Locations
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 identifier: NCT01315808

United States, New York
Wyckoff Heights Medical Center
Brooklyn, New York, United States, 11237
Sponsors and Collaborators
Wyckoff Heights Medical Center
Principal Investigator: Rekha Bhandari, MD Wyckoff Heights Medical Center, Brooklyn New York
Principal Investigator: Shitij Arora, MD Wyckoff Heights Medical Center
  More Information

Responsible Party: Rekha Bhandari, Wyckoff Heights Medical Center Identifier: NCT01315808     History of Changes
Other Study ID Numbers: whmc1
Study First Received: March 14, 2011
Last Updated: March 18, 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on September 21, 2017