Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

Journal：Scientific reports

Publication type: Original Contributions

IF(IF): 4.379

PMID: 2016; 6:36220. Link To Pubmed Full text Download

This study aimed at observing the influence of impaired glucose regulation (IGR) on 1-year outcomes in patients with intracerebral hemorrhage (ICH). Patients hospitalized for ICH from 2008 to 2009 were recruited consecutively at 35 centres across China. A standard oral glucose tolerance test at day 14 ± 3 after stroke onset or before discharge was performed to identify IGR. The outcomes were death (modified Rankin scale [mRS] score of 6), dependency (mRS score of 2 to 5) and poor outcome (mRS score of 2 to 6) at 1 year. Cox proportion hazard model for death and logistic regression model for dependency and poor outcome were performed to investigate the influence of IGR on 1-year outcomes. A total of 288 non-diabetic ICH patients were included in this analysis, among which 150 (52.1%) were IGR. IGR was associated with 1-year dependency (adjusted odds ratio [OR] 2.18, 95% confidence interval [CI], 1.19–3.99; P= 0.01) and poor outcome (adjusted OR 2.17; 95% CI, 1.24–3.80; P= 0.007) of patients with ICH. However, IGR showed no significant association with 1-year death (adjusted hazard ratio 1.49, 95% CI, 0.60–3.67; P = 0.39). IGR was independently associated with 1-year poor outcome of ICH in Chinese patients, with more important influence on dependency than death.

tudy Population. The study population was derived from the study of ACROSS-China, the baseline char- acteristics and recruiting criteria of which have been described in detail elsewhere29. In brief, ACROSS-China was a nationwide, multicenter and prospective cohort study, aimed at investigating the prevalence and influence of abnormal glucose regulation among patients hospitalized with acute stroke. Patients with ischemic stroke, ICH, or subarachnoid hemorrhage (SAH) within 14 days after onset were recruited consecutively from 35 participating hospitals across China from August 2008 to October 2009. A standard OGTT was performed in all the partic- ipants without previously known DM at the day 14 ± 3 after stroke onset or before discharge according to the World Health Organization (WHO) criteria33. ACROSS-China was performed in accordance with the guidelines of the Helsinki Declaration. The protocol and data collection were approved by the Ethics Committees at Beijing Tiantan Hospital and all participating hospitals. Written informed consent was obtained from each participant or his/her designated relatives. Acute stroke was diagnosed according to WHO criteria34 combined with brain CT or MRI confirmation. For the current study, patients with ischemic stroke and SAH were excluded. We also excluded patients with previ- ously known DM, no OGTT performed, NDM based on OGTT results and patients lost to follow-up. Data Collection and Variable Definition. Demographic characteristics, clinical information, status on admission including stroke severity and blood pressure values, hematoma locations, laboratory values on admis- sion, treatment during hospitalization and OGTT results were collected from the database. Stroke severity was measured using the initial NIHSS score and GCS score. The definition of NGR, IGR and NDM were based on the OGTT results. According to the WHO criteria35, IGR was defined as having isolated IFG (FPG≥6.1 mmol/L and <7.0 mmol/L, meanwhile, 2-h plasma glucose [2-h PG] <7.8 mmol/L), or isolated IGT (FPG <6.1 mmol/L, meanwhile, 2-h PG ≥7.8 mmol/L and <11.1 mmol/L), or complex IGT (FPG ≥6.1 mmol/L and <7.0 mmol/L, meanwhile, 2-h PG ≥7.8 mmol/L and <11.1 mmol/L). NGR was defined as FPG <6.1 mmol/L and 2-h PG <7.8 mmol/L. NDM was defined as FPG ≥7.0 mmol/L and/or 2-h PG ≥11.1 mmol/L. Patients with self-reported physician diagnosis of DM or hypoglycemic treatment before ICH were classified as those with previously known DM. Outcome Measures. The outcomes were all-cause death (modified Rankin scale [mRS] score of 6), depend- ency (mRS score of 2 to 5) and poor outcome defined as mRS score of 2 to 6 at 1 year36. The 1-year follow-up of participants were conducted by trained research personnel at Beijing Tiantan Hospital. The mRS score at 1 year after onset of ICH were recorded through telephone interview. A death certificate from the local citizen registry or the attended hospital was used to confirm the case fatality. Statistical Analysis. Baseline demographic and clinical characteristics were expressed as mean (standard deviation) or median (interquartile range) for continuous variables and as percentages for categorical varia- bles. The chi-square test for categorical variables and Mann–Whitney test for continuous variables were used as needed. Cox proportion hazard model for death and logistic regression model for dependency and poor out- come were performed both in univariable and multivariable analyses to show the association between IGR and outcomes. HRs and ORs with 95%CI were calculated. Age, gender and all significant baseline variables in the univariable analysis were included in the multivariable analysis. A 2-sided P value< 0.05 was set as the level for statistical significance. All analyses were performed with SAS software version 9.4 (SAS Institute Inc, Cary, NC, USA).