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Table 1 Primary and secondary outcome measures

From: Does metformin improve vascular health in children with type 1 diabetes? Protocol for a one year, double blind, randomised, placebo controlled trial

  Baseline 3 months 6 months 12 months
Primary outcome
Vascular endothelial function (FMD) * * * *
Secondary outcomes
Vascular smooth muscle function (GTN) * * * *
Vascular structure (cIMT and aIMT) *    *
Physical examination * * * *
- anthropometric measurements (height, weight, BMI, waist circumference)
- the presence of acanthosis nigricans
- severity of acne
- ferriman - gallwey score (girls)
Frequency and severity of hypoglycaemia * * * *
Insulin dose (units/kg/day) * * * *
Glycosylated haemoglobin * * * *
Fasting glucose * * * *
Fasting total/HDL/LDL cholesterol/triglycerides * * * *
High sensitivity C-Reactive Protein (HsCRP) * * * *
Early morning urinary albumin/creatinine * * * *
Urinary prostaglandin F2α * * * *
Liver function, renal function tests and lactate * * * *
Total Plasma homocysteine * * * *
Girls only: Testosterone, free androgen index, Sex Hormone-Binding Globulin, Dehydroepiandrosterone, Anti-Mullerian Hormone, 17-hydroxy progesterone, prolactin, Luteinizing hormone, Follicle Stimulating Hormone, progesterone & oestradiol * * * *
Total Adiponectin * * * *
Leptin * * * *
Body composition (bio-electrical impedance analysis using Tanita body composition scales) * * * *
Retinal photograph *    *
Total body Dual-energy X-ray absorptiometry scan *    *
  1. *Indicates assessment of a variable at the timepoint indicated.