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Opportunistic Screening for Prediabetes and Early Diabetes in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00787839
First received: November 6, 2008
Last updated: December 19, 2014
Last verified: December 2014
History of Changes
Results First Received: December 5, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Conditions: Type 2 Diabetes Mellitus
Prediabetic State
Interventions: Other: Glucose challenge test
Other: Glucose tolerance test

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Atlanta VA patients without known diabetes, who were at high risk of having unrecognized dysglycemia based on age >=45 years, BMI >=25 kg/m2, or other risk factors, were eligible for the study. Patients presenting for primary care visits were approached if they appeared to have age >=45 years and BMI >=25 kg/m2.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1

Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.

Glucose challenge test: At a first outpatient visit, at different times of the day and without a prior fast, subjects will have a 50 gram glucose drink followed by measurement of plasma and capillary glucose along with A1c one hour later. They will also fill out questionnaires. At a second outpatient visit, in the morning after fasting overnight, they will have a 75 gram oral glucose tolerance test.

Glucose tolerance test: Subjects found to have diabetes or prediabetes on the initial glucose tolerance test may be requested to have a repeat glucose tolerance test and A1c.

Participant Flow:   Overall Study
    Group 1  
STARTED     1939  
Consented     1939 [1]
Completed GCT Screening     1876  
Complete GCT, OGTT, A1c, Demographics     1535  
COMPLETED     1535  
NOT COMPLETED     404  
Failure to have the OGTT was most common                 404  
[1] consented



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Individuals receiving care at the Atlanta VA Medical Center

Reporting Groups
  Description
Group 1 Atlanta VA Medical Center patients who meet criteria for screening for prediabetes and early diabetes based on standard guidelines of the VA, American Diabetes Association, and NIH. This primarily included outpatient Veterans. Subjects were primarily included if they had age at least 45 years and BMI of 25 or greater, but some younger subjects were also included if they had risk factors for diabetes.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
 		  1535  
Age  
[units: years]
Mean ± Standard Deviation 		  56.1  ± 9.93  
Gender  
[units: participants]
 		 
Female     94  
Male     1441  
Region of Enrollment [1]
[units: participants]
 		 
United States     1535  
BMI  
[units: kg/m2]
Mean ± Standard Deviation 		  30.3  ± 5.20  
[1] Individuals receiving care at the Atlanta VA Medical Center



  Outcome Measures
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1.  Primary:   Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)   [ Time Frame: 3 years ]
  Show Outcome Measure 1

2.  Secondary:   Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes   [ Time Frame: 3 years ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study in a single healthcare system, in a convenience sample of patients receiving care in a VA primary care clinic, in a population that was largely older, heavier, and predominantly male, and a single OGTT was used as the “gold standard”.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lawrence S Phillips, MD
Organization: Atlanta VA Medical Center
phone: 404-728-7608
e-mail: lawrence.phillips@va.gov


Publications:


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00787839     History of Changes
Other Study ID Numbers: IIR 07-138
Study First Received: November 6, 2008
Results First Received: December 5, 2014
Last Updated: December 19, 2014
Health Authority: United States: Federal Government