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

Terminated

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT01315808
• Lead Sponsor: Wyckoff Heights Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-18
• Last Update Posted: 2012-03-20
• Primary Completion: 2012-07
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 542

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study the rate of change of HbA1c in normal population with known risk factors of diabetes	one year

Secondary Outcome Measures

Name	Time	Method
Diabetes prediction model based on the rate of change in HbA1c	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

Trial Locations

Locations (1)

Wyckoff Heights Medical Center; 🇺🇸 Brooklyn, New York, United States