Table 4.
Testa | Construct assessed and/or rationale | Consent visit: eligibility screening | Assessment: baseline | Assessments: 3 and 6 months |
Glycosylated hemoglobin | Inclusionary test and study variable: level of overall glucose control | ✓ | ✓ | ✓ |
C-peptide | Inclusionary testb: confirms type 2 diabetes among individuals using exogenous insulin | ✓ | — | — |
Thyroid stimulating hormone | Exclusionary test: rules out an untreated thyroid disorder | ✓ | — | — |
Comprehensive metabolic panel | Exclusionary test: rules out liver and/or kidney dysfunction; study variable: liver enzymes | ✓ | ✓ | ✓ |
Glucose, plasma | Study variable: allows for calculation of insulin resistance and fasting glucose | — | ✓ | ✓ |
Insulin, plasma | Study variable: allows for calculation of insulin resistance and fasting glucose | — | ✓ | ✓ |
High-sensitivity C-reactive protein | Study variable: biomarker of inflammation | — | ✓ | ✓ |
NMR LipoProfile | Study variables: triglycerides and detailed cholesterol measures | — | ✓ | ✓ |
aAll samples are collected from individuals in a fasting state.
bWe assess C-peptide only among potential participants reporting insulin use or a history of diabetic ketoacidosis.