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

Wyckoff Heights Medical Center

Status: Terminated

Conditions: Diabetes Mellitus Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT01315808

whmc1

Details and patient eligibility

About

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.

Enrollment: 542 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

542 participants in 3 patient groups

Low risk group

Description:

Patients will be stratified based on risk factors significantly contributing to diabetes type 2.

Intermediate risk group

High risk group