Rate of Change of HbA1c (dx/dt) May Predict Progression to Type 2 DM

March 18, 2012 updated by: Wyckoff Heights Medical Center

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)

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.

Study Overview

Status

Terminated

Study Type

Observational

Enrollment (Actual)

542

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Brooklyn, New York, United States, 11237
        • Wyckoff Heights Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will recruit 1000 non-diabetes people those having at least one diabetes prone risk factor.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study the rate of change of HbA1c in normal population with known risk factors of diabetes
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rekha Bhandari, MD, Wyckoff Heights Medical Center, Brooklyn New York
  • Principal Investigator: Shitij Arora, MD, Wyckoff Heights Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 18, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus Type 2

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