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participant burden during the visit



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participant burden during the visit. 
5.1.3.
 
Summary of Measurements 
Table 5-2 shows measures for the SEARCH Cohort Study.  All data collection is 
performed under standardized protocols by centrally trained and certified staff. 
 


Section 5B - Data Collection (Phase 3 - 1/2011, rev. 8/2011) 
Section 5B - Page 3 
 Cohort 
Study
 
Table 5-2.  Summary of Data Available from SEARCH 1 and SEARCH 2 for Incident Cases Eligible for the 
SEARCH Cohort Study, and Measures Proposed for the SEARCH Cohort Study 
 
Brief Medical Record (e.g., DM type, Dx date) 
Medical Record Validation of Self-Report (subset) 
Demographics and socioeconomic status indicators 
Family Medical History 
Health Questions 

Serious acute complications (hypoglycemia, DKA), 

Medications 

Hospitalization 

Other processes of care including transition 

Quality of care 

Family structure 

Quality of life (PedsQL) 
Additional for age > 10 yr:  

Tanner stage (age < 18 yr) 

Parent and Participant Education 

Diet (food frequency questionnaire) 

Physical activity 

Tobacco Use, Secondhand smoke 

Alcohol 

Depressive symptoms (CES-D) 

Pregnancy 
Hypoglycemia Fear Survey 
Diabetes Family Interaction Scale 
Diabetes Eating Problems Survey 
Expansion of transition from pediatric to adult care 
(processes, satisfaction and type of transition)  
Physical Exam (anthropometry, BP, acanthosis) 
Retinopathy, retinal vessel caliber (fundus photos) 
Peripheral Neuropathy (MNSI) 
Cardiac autonomic neuropathy (HRV) 
Arterial stiffness (PWV, Alx) 
Laboratory 
Fasting glucose, DAA (GAD65, IA2, ZnT8 (once assay is standardized), fasting C-peptide, lipids (total 
cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides), A1c; apoB, LDL particle size and density, 
cystatin-c 
CRP, IL-6, DGUC Rf, fibrinogen, adiponectin, leptin, creatinine, random and first morning 
void for urinary albumin and creatinine, storage of plasma, serum, DNA; storage of first morning void 
urine
 
5.1.4.
 
Risk Factors for Complications: Dimensions of Diabetes 
In addition to diabetes type as established by the health care provider, we assess markers 
of autoimmunity (diabetes autoantibodies, GAD65, IA2; plus the addition of the recently 
identified ZnT8 antibody 
(1)
 once assays are standardized) and fasting c-peptide 
(2, 3)
 and 
fasting glucose. 


Section 5B - Data Collection (Phase 3 - 1/2011, rev. 8/2011) 
Section 5B - Page 4 
 Cohort 
Study
 
5.1.5.
 
Risk Factors for Complications: Other Laboratory, Physical Exam, and Health 
Behaviors 
A1c is the primary marker of glycemia.  Lipid profile includes total, LDL- and HDL-
cholesterol, and triglycerides.  Additionally, we will measure apolipoprotein B, and LDL 
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