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Table 2 Primary and secondary outcomes

From: Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial

Endpoint events
Primary outcomes
 Glycemic parameters Normal range reference
 Fasting blood glucose < 100.9 mg/dL
 Glycosylated hemoglobin/HbA1c < 5.7%
 Fructosamine 200–285 μmol/L [63]
 GlycoMark ~ 180 mg/dL
 Fasting insulin < 25 μU/L
 Absence of high HOMA-Insulin Resistance General US adult population: < 2.73 vs. ≥ 2.73 [63]
 Quantitative Insulin Sensitivity Check Index ~ 100% [66]
 Pancreatic β-cell function ~ 100% [66]
Secondary outcomes
 Lipid profile
  Total cholesterol ≤ 19 years: < 170 mg/dL; ≥ 20 years: 125–200 mg/dL
  Low-density lipoprotein < 100 mg/dL
  High-density lipoprotein ≤ 19 years: > 45 mg/dL; ≥ 20 years men: ≥ 40 mg/dL; ≥ 20 years women: ≥ 50 mg/dL [129]
  Triglycerides < 150 mg/dL [130]
 Inflammation
  High-sensitivity C-reactive protein (hs-CRP) Variesa
Progression to type-2 diabetes (T2D) (according to 2016 ADA diagnostic criteria [39, 40])
  1. ADA American Diabetes Association, HbA1c glycated hemoglobin/HbA1c, HOMA-IR homeostatic model of Insulin Resistance, US United States
  2. aElevated CRP levels indicate increased risk of T2DM [131] with normal CRP range 0.0–5.0 mg/L [132], while hs-CRP reference values applicable to cardiovascular risk assessment are < 2.0 mg/L [133]