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Opportunistic Screening for Prediabetes and Early Diabetes in Primary Care

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ClinicalTrials.gov Identifier: NCT00787839
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : December 23, 2014
Last Update Posted : April 27, 2015
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
VA Office of Research and Development

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

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

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 
Overall Participants Analyzed 
[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 
[1] Individuals receiving care at the Atlanta VA Medical Center
BMI 
[Units: Kg/m2]
Mean (Standard Deviation) 		 30.3  (5.20) 


  Outcome Measures

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


  Other Adverse Events


  Limitations and Caveats

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

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 of Results:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00787839     History of Changes
Other Study ID Numbers: IIR 07-138
First Submitted: November 6, 2008
First Posted: November 10, 2008
Results First Submitted: December 5, 2014
Results First Posted: December 23, 2014
Last Update Posted: April 27, 2015