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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]