Table 1 Primary and secondary outcome measures
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 | * | * | ||