Microsoft Word search phase 3 Title Page Amendment

In-Person Research Visit (IPV):  The IPV or “registry visit” in SEARCH 3 is designed 
to collect data on relevant dimensions of diabetes type (presence of autoimmunity, 
genetic susceptibility to autoimmunity, insulin sensitivity, insulin secretion) and data 
informing the clinical presentation of diabetes.  We will also store (by separate consent) 
blood, serum, plasma and urine for future genetic and non-genetic analyses.  In keeping 
with the time-stratified sampling approach initiated in SEARCH 2, only the incident 2012 
cohort will be eligible to participate in the registry visit.  An additional sampling 
approach will be implemented in SEARCH 3, in order to reduce participant burden and 
maximize study resources, without compromising the statistical power to detect trends in 
clinical characteristics over time.  To maximize the number of minority participants and 
youth with T2D, eligible cases for SEARCH 3 registry visit are all cases >10 years old, 
regardless of ethnicity/race, all minority cases, regardless of age, all cases not T1, 
regardless of race or age, and 50% of NHW T1 cases <10 years old.  Since some sites are 
not able to obtain race at the time of the assignment of the PID, if race is not available, all 
participants will be invited to the IPV.  We will seek a 70% completion of the IPV among 
eligible youth. 
 
 
 

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Section 5A - Case Ascertainment & Data Collection (Phase 3 - 1/2011) 
Section 5A - Page 4 
 
Registry Study (rev. 8/2011)
 
The content of the IPV for incident cases will be similar to SEARCH 1 and 2 (Table 5 - 
1).  However, unique to SEARCH 3, we will add a first morning void urine collection 
that the participant will bring to the clinic.  Urinary albumin and creatinine will be 
measured to obtain an albumin/creatinine ratio on a spot urine sample.  Samples will not 
be collected during the visit on participants who are pregnant or menstruating, have had a 
fever greater than 100 degrees in the past two hours, or who have taken an antibiotic in 
the past seven days for a urinary tract infection.  A dipstick test will also be performed to 
test for the presence of blood or leukocytes by the central laboratory.  Urine will also be 
stored (first morning void only) to assess other markers of nephropathy in the future. 
(8/11)   
The following will be collected for the IPV incident cases:  fasting blood and urine for 
laboratory measurements and storage, and a brief physical examination as outlined 
below.   
•
 
Blood measures:  Diabetes autoantibodies (GAD65, IA-2); (ZNT8 will be added 
after the assay is standardized); HbA
1c
, fasting glucose and C-peptide, lipids (total 
Table 5-1: Summary of SEARCH3 Registry Data Collection 
 
Eligible 
Cohorts 
Core Variables 
Clinical Presentation 
MRA 2010-2014 
Date of birth, date of 
diagnosis, sex, provider-
determined diabetes type, 
race/ethnicity, residence in 
the year of diagnosis 
Weight/height at diagnosis, DKA at 
diagnosis, insulin use, acanthosis 
nigricans, diabetes autoantibodies and 
c-peptide assessment 
IPS 2010-2014 
Date of birth, date of 
diagnosis, sex, self-reported 
race/ethnicity, residence in 
the year of diagnosis; health 
insurance; usual diabetes 
care, education of parents; 
youth > 18 yrs. 
Treatment history, secondary diabetes, 
symptoms at presentation, acute 
complications, medications, family 
history, contact information; reported 
height, weight 
IPV 2012 
 
Physical Exam: height, weight, waist 
circumference, BP, acanthosis 
nigricans 
Medication Inventory:  list of currently 
prescribed medications 
Lab/specimens: diabetes autoantibodies 
(GAD65, IA2), HbA
1c
, fasting glucose, 
C-peptide, lipids, urinary 
albumin/creatinine (spot sample) 
Repository: serum, plasma, DNA (by 
separate consent) and urine for storage 
on 1
st
 morning void 

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Section 5A - Case Ascertainment & Data Collection (Phase 3 - 1/2011) 
Section 5A - Page 5 
 
Registry Study (rev. 8/2011)
 
cholesterol, HDL-Cholesterol, LDL-Cholesterol, triglycerides), HLA risk 
genotypes  
•
 
Urine measures (spot and first morning void):  Urinary albumin and creatinine 
(from spot urine collection) 
•
 
Physical examination:  Height, weight, blood pressure, assessment of acanthosis 
nigricans, waist circumference (NHANES and minimum waist methods) on