Blood/urine sampling and data collection
HbAVenous blood samples, diabetes
ADVERSE EVENT, EVENTS, TYPE 2 DIABETES, DIABETES
On arrival at the clinic, a morning blood sample was collected via venepuncture by a research nurse, and fasting blood glucose was measured. Participants were given a 75 g anhydrous glucose solution dissolved in 300 ml non-carbonated water (Rapilose OGTT solution; Galen, Craigavon, UK) and a 2 h post glucose-load capillary blood glucose measurement was taken via finger prick. To determine glucose, a point-of-care test was performed (HemoCue Glucose 201 RT; Hemocue, Ängelholm, Sweden) immediately following venepuncture and finger prick. Further screening investigations included HbAVenous blood samples were collected every 3 months from enroled participants on arrival to the clinic. Full blood count (FBC), and analysis of total cholesterol, LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C) and triglyceride levels were conducted at baseline and at the 12 month visit only. For the FBC, blood samples were in EDTA tubes and for biochemical analyses, blood samples were in plain tubes; these samples were transported to a centralised laboratory for processing within 2–3 h of procurement (the mean time between collection and processing was 11 h). The Architect C4100 analyser (Abbott, IL, USA) was used for biochemical analysis, whilst the CELL-DYN 3700 and CELL-DYN Ruby analysers (both Abbott) were used for haematological (FBC) analysis.Participants with suspected clinical conditions and/or abnormal laboratory markers identified through screening or enrolment procedures were referred to the appropriate clinics within the health facility. Any participants with raised BP, above 180/120 mmHg, were referred to the emergency department for immediate care. Participants in the trial who developed type 2 diabetes were referred to the diabetes service within the health facility. Adverse events were graded using the DAIDS criteria, and events that were Grade 3 or greater were reported as SAEs [Anthropometric measurements included height, weight, and waist and hip circumference, all of which were measured following removal of shoes and outer clothing. Height was measured to the nearest 1 cm using calibrated stadiometers (Seca, Hamburg, Germany) and weight to the nearest 1 kg. using calibrated Seca scales. Flexible tape measures were used to measure waist and hip circumference. The WHO definitions of threshold values were used for classifying BMI, waist circumference and waist:hip ratio [