Rate of Change of HbA1c (dx/dt) May Predict Progression t... | NCT01315808

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

NCT01315808

Sponsor

Wyckoff Heights Medical Center

Status

Terminated

Last Update Posted

Mar 20, 2012Estimated

Enrollment

542Actual

Phase

Not provided

Conditions

Diabetes Mellitus Type 2

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to lack of funds to continue this study.

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Mar 14, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

542Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low risk group		Patients will be stratified based on risk factors significantly contributing to diabetes type 2.
Intermediate risk group
High risk group

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Diabetes prediction model based on the rate of change in HbA1c	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rekha Bhandari, MD	Wyckoff Heights Medical Center, Brooklyn New York	Principal Investigator
Shitij Arora, MD	Wyckoff Heights Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wyckoff Heights Medical Center		Brooklyn	New York	11237	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided