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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315808
First Posted: March 15, 2011
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyckoff Heights Medical Center
  Purpose
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.

Condition
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)

Resource links provided by NLM:


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)
Groups/Cohorts
Low risk group
Patients will be stratified based on risk factors significantly contributing to diabetes type 2.
Intermediate risk group
High risk group

  Eligibility

Information from the National Library of Medicine

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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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315808


Locations
United States, New York
Wyckoff Heights Medical Center
Brooklyn, New York, United States, 11237
Sponsors and Collaborators
Wyckoff Heights Medical Center
Investigators
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
ClinicalTrials.gov Identifier: NCT01315808     History of Changes
Other Study ID Numbers: whmc1
First Submitted: March 14, 2011
First Posted: March 15, 2011
Last Update Posted: March 20, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases