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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