Table 5 Overview of outcomes and variables designated article 1 concerning β-cell function
Outcome | Time frame | Domain | Measurements |
|---|---|---|---|
Primary | Baseline and after 16 weeks | β-cell function | Late-phase DI from hyperglycaemic phase |
Secondary | Baseline and after 16 weeks | Secondary measures of pancreatic α- and β-cell function. | Hyperglycaemic clamp • GLP-1 stimulated insulin, C-peptide and glucagon secretion • Arginine stimulated insulin, C-peptide and glucagon secretion • 1st phase C-peptide and insulin secretion defined as the peak concentration during the initial 10 min of the hyperglycaemic clamp • Late-phase SI (mean Glucose infusion rate over last 30 min of clamp phase/ (mean insulin × glucose)) • Early phase DI (DI from 0 to 30 min) • Rate of glucose disappearance (Rd) • Rate of glucose appearance (Ra) |
Secondary | Baseline and after 16 weeks | Post prandial glycaemic control | Mixed meal tolerance test (MMTT) • iAUC of glucose, insulin, glucagon and C-peptide • tAUC of glucose, insulin, glucagon and C-peptide • Indices of insulin secretion, insulin sensitivity and β-cell function |
Secondary | Baseline and after 16 weeks | Visceral and organ-specific fat content | Magnet Resonance (MR) |
Secondary | Baseline and after 16 weeks | Body anthropometrics | • Body weight • Body mass index • Lean body mass • Total fat mass |
Secondary | Baseline, 4 weeks, 12 weeks and after 16 weeks | Blood glucose control | • HbA1c • Fasting glucose • Fasting C-peptide and insulin |
Secondary | Baseline, 4 weeks, 12 weeks and after 16 weeks | Blood lipids | • Total cholesterol • Triglyceride • Low- and high-density lipoprotein |
Secondary | Baseline, 4 weeks, 12 weeks and after 16 weeks | Blood pressure | • Resting systolic and diastolic blood pressure |
Secondary | Baseline and after 16 weeks | Gastric emptying | Mixed meal tolerance test (MMTT) • Rate of appearance of paracetamol |
Secondary | Baseline and after 16 weeks | Physical fitness | • Maximal aerobic capacity (VO2 peak) • One-repetition maximum (RM) strength |
Secondary | Baseline and after 16 weeks | Incretin response | Mixed meal tolerance test (MMTT) • Blood levels of incretins |