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Table 2 Summary of the methodology of primary and secondary outcome measurements and potential confounders in the PREvention of DIabetes in KIDs (PREDIKID) study

From: Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial

Measure

Methodology

Primary outcomes

 Insulin resistance

Homeostatic model assessment (HOMA), biochemical analyses

 Expression of miRNA in circulating exosomes and white blood cells

RNA-seq methodology

Secondary outcomes

 Physical measures

  Body mass (kg)

Scale

  Height (cm)

Stadiometer

  Waist circumference (cm)

Non-elastic tape

  Blood pressure (mmHg)

Oscillometric monitor device

  Body fat (%)

Dual X-ray absorptiometry

  Abdominal adiposity (g)

Dual X-ray absorptiometry

  Visceral abdominal adiposity (cm2)

Magnetic resonance imaging

  Hepatic fat (%)

Magnetic resonance imaging

  Pancreatic fat (%)

Magnetic resonance imaging

  Carotid intima medial thickness (mm)

Doppler ultrasonography

 Biochemical measures

  Glucose (mg/dL)

Enzymatic spectrophotometry

  Insulin, leptin, adiponectine, fetuin-A, FGF21

Enzyme-Linked Immunosorbent Assay

  Hemoglobin A1c

Enzymatic tests

  Total cholesterol, HDL- and LDL-cholesterol (mg/dL)

Enzymatic spectrophotometry

  Triglycerides (mg/dL)

Enzymatic spectrophotometry

  Alanine aminotransferase (U/L)

Enzymatic tests

  Aspartate aminotransferase (U/L)

Enzymatic tests

  Gamma glutamyl transferase (U/L)

Enzymatic tests

  C-reactive protein (g/dL)

Enzyme immunoassay

  TSH, T3, T4

Radioimmunoassay

  Uric acid (mg/dL)

Enzymatic spectrophotometry

  Urea, bilirubin

Enzymatic spectrophotometry

 Cardiorespiratory fitness

20-m shuttle run test

Cardiopulmonary exercise test

 Dietary assessment

24-h recalls and food frequency questionnaires

 Physical activity assessment

Accelerometry and questionnaires

 Sleeping habits

Accelerometry and questionnaires

 Sedentary behaviors

Questionnaires

Potential confounders

 Pubertal development (Tanner stage)

Physical examination

 Sociodemographic variables

 Socioeconomic status

Questionnaires

 Neonatal variables

Health booklets and questionnaires

 Family medical history

Questionnaires

 Demographic characteristics

Questionnaires

  1. PREDIKID Prevention of Diabetes in Kids; FGF21 fibroblast growth factor 21; HDL high-density lipoprotein; LDL low-density lipoprotein; miRNA micro RNA; TSH thyroid stimulating hormone; T3 triiodothyronine; T4 free thyroxine