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	*			*

*Indicates assessment of a variable at the timepoint indicated.