Hypertriglyceridaemic-waist phenotype and risk of diabetes in people with impaired fasting glucose in primary care: a cohort study.

AIM: We aimed to determine the prospective association between baseline triglyceridaemic-waist phenotypes and diabetic mellitus incidence in individuals with impaired fasting glucose seen in primary care. METHODS: A cohort of 1101 participants (84.4% of the recruited individuals) with impaired fasting glucose were recruited from three primary care clinics during regular follow-ups to monitor their chronic conditions. Baseline triglyceridaemic-waist phenotypes were divided into four groups: (1) normal waistline and triglyceride level (n = 252); (2) isolated central obesity (n = 518); (3) isolated high triglyceride level (n = 80); and (4) central obesity with high triglyceride level (i.e. hypertriglyceridaemic-waist phenotype) (n = 251). The presence of diabetes at follow-up was determined by fasting plasma glucose (≥ 7.0 mmol/l) and/or 2-h 75-g oral glucose tolerance test (≥ 11.1 mmol/l) and/or HbA1c (47.5 mmol/mol; ≥ 6.5%) according to American Diabetes Association diagnostic criteria. Multivariable Cox proportional hazards regressions were established to assess the impact of different triglyceridaemic-waist phenotypes on time to diabetes onset. RESULTS: After a mean follow-up period of 6.5 months (sd 4.7 months), the number of diabetes cases was significantly higher in the group with hypertriglyceridaemic-waist phenotype (52.2%) compared with the other three phenotype groups (group 1: 28.2%; group 2: 34.6%; group 3: 30.0%). Only the hypertriglyceridaemic-waist phenotype showed an increased risk of developing diabetes (hazard ratio 1.581, 95% CI 1.172-2.134; P = 0.003) compared with the group with normal waistline and triglyceride level after controlling for confounders. CONCLUSIONS: The combination of central obesity and hypertriglyceridaemia is associated with > 50% risk of progression to diabetes within 6 months among individuals with impaired fasting glucose seen in primary care.

Cross-clade immunogenicity and safety of an AS03A-adjuvanted prepandemic H5N1 influenza vaccine in Hong Kong.

OBJECTIVE: To present Hong Kong'Äìspecific data from a large Asian population (also involving Thailand, Singapore, and Taiwan) on safety and manufacturing consistency across four AS03(A)-adjuvanted H5N1 vaccine formulations in terms of immune response against the A/Vietnam/1194/2004 strain. Immunogenicity against the heterologous A/Indonesia/05/2005 strain was also assessed. NCT Number: 00449670. DESIGN: Prospective, observer-blind study. SETTING: Out-patient clinic of a tertiary hospital in Hong Kong. PARTICIPANTS: A total of 360 subjects aged 18 to 60 years were randomised into six groups to receive two doses (21 days apart) of the study vaccine. INTERVENTIONS: One of the four adjuvanted formulations (3.75 microgram H5N1 haemagglutinin [HA]+AS03(A)) of the vaccine (H5N1-AS03(A)) or one of the two non-adjuvanted (3.75 microgram H5N1 [HA]) formulations of the vaccine (H5N1-DIL). MAIN OUTCOME MEASURES: Blood samples collected before vaccination and 21 days after each vaccine dose were analysed using haemagglutination-inhibition and neutralisation assays. Solicited, unsolicited, and serious adverse events were recorded. RESULTS: Manufacturing consistency across all four vaccine formulations was demonstrated. After two doses, the AS03(A)-adjuvanted prepandemic influenza vaccine demonstrated high seroprotection rates against the A/Vietnam/1194/2004 strain (95.8%) and good immunogenicity against the heterologous A/Indonesia/05/2005 strain (45.7%), as compared to the non-adjuvanted vaccine (4.6% and 1.5%, respectively). The seroconversion rates induced by the adjuvanted formulations in terms of viral neutralising antibodies against the two strains were much higher than those induced by the non-adjuvanted formulations. There were no safety concerns for any of the adjuvanted vaccine formulations. CONCLUSIONS: The AS03(A)-adjuvanted H5N1 prepandemic influenza vaccine demonstrated good immunogenicity and an acceptable safety profile in Hong Kong.