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:
Information provided by:
Wyckoff Heights Medical Center
ClinicalTrials.gov Identifier:
NCT01315808
First received: March 14, 2011
Last updated: March 18, 2012
Last verified: March 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diabetes prediction model based on the rate of change in HbA1c [ Time Frame: one year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rekha Bhandari, Wyckoff Heights Medical Center
ClinicalTrials.gov Identifier: NCT01315808     History of Changes
Other Study ID Numbers: whmc1
Study First Received: March 14, 2011
Last Updated: March 18, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014