Background: Previous studies in mostly Western populations, have yielded conflicting findings on the association of vitamin B12 with diabetes risk, in part, due to differences in study design and population characteristics. This study sought to examine the vitamin B12 – diabetes association in Chinese hypertensive adults by both cross-sectional and longitudinal analyses. Methods: This report included a total of 16699 participants from the China Stroke Primary Prevention Trial (CSPPT), with pertinent baseline and follow-up data. Diabetes mellitus (DM) was defined as either physician-diagnosed diabetes, the use of glucose-lowering drugs, or fasting blood glucose (FBG) ≥7·0 mmol/L. New-onset diabetes was defined as any new case of onset diabetes during the follow-up period or fasting blood glucose (FBG) ≥7·0 mmol/L at the exit visit. Findings: At baseline, there were 1872 (11 ·2%) diabetic patients; less than 1·5% had clinical B12 deficiency (<148·0 pmol/L). Over a median follow-up period of 4·5 years, there were 1589 (10·7%) cases of new-onset diabetes. Cross-sectional analyses showed a positive association between baseline vitamin B12 levels and FBG levels (β=0·18, 95%CI [0·15, 0·21], p <0·001) and diabetes (OR=1·42, 95%CI [1·33, 1·51], p <0·001). However, longitudinal analyses showed no association between baseline vitamin B12 and new-onset diabetes (OR=1·01, 95%CI [0·94, 1·09] , p = 0·734) or changes in FBG levels (β= -0·02, 95%CI [-0·05, 0·01], p =0·154). Among a subset of the sample (N=4366) with both baseline and exit B12 measurements, we analyzed the relationship between the change in B12 levels and the change in FBG levels from the baseline to the exit visit, and found a positive association between an increase in B12 and an increase in FBG. Interpretation: In this large Chinese hypertensive population mostly sufficient with vitamin B12, parallel cross-sectional and longitudinal analyses provided new insight into the conflicting findings of previous studies, and these results underscore the need for future studies to consider both baseline vitamin B12 and its longitudinal trajectory in order to better elucidate the role of vitamin B12 in the development of diabetes. Such findings, if further confirmed, would have important clinical and public health implications. Funding Statement: The China Stroke Primary Prevention Trial (CSPPT) was jointly supported by Shenzhen AUSA Pharmed (Shenzhen, China) and national, provincial and private funding, including from the Major State Basic Research Development Program of China (973 program; grant no. 2102 CB517703); the National Science and Technology Major Projects Specialized for “Innovation and Development of Major New Drugs” during the 12th Five-year Plan Period: the China Stroke Primary Prevention Trial (grant no. zx09101105), a Clinical Center grant (no. zx09401013); the Projects of the National Natural Science Foundation of China (grant no. 81473052, 81441091, and 81402735); the National Clinical Research Center for Kidney Disease, Nanfang Hospital, Nanfang Medical University, Guangzhou, China; the State Key Laboratory for Organ Failure Research, Nanfang Hospital; and research grants from the Department of Development and Reform, Shenzhen Municipal Government (grant no. SFG 20201744). Declaration of Interests: Dr. Xiping Xu reports grants from the National Key Research and Development Program [2016YFE0205400, 2018ZX09739010, 2018ZX09301034003], the Science and Technology Planning Project of Guangzhou, China [201707020010], the Science, Technology and Innovation Committee of Shenzhen [JSGG20170412155639040, GJHS20170314114526143, JSGG20180703155802047], the Economic, Trade and Information Commission of Shenzhen Municipality [20170505161556110, 20170505160926390]. Dr. Youbao Li reports grants from the President Foundation of Nanfang Hospital, Southern Medical University [2017C007, 2018Z009]. Dr. Xianhui Qin reports grants from the National Natural Science Foundation of China [81730019, 81973133], Outstanding Youths Development Scheme of Nanfang Hospital, Southern Medical University [2017J009]. Dr. Huiyuan Guo reports grants from the 111 project from the Education Ministry of China [No. B18053]. Dr. Xiao Huang reports grants from the National Natural Science Foundation of China [81960074, 81500233], Jiangxi Outstanding Person Foundation [20192BCBL23024], Major projects of the Science and Technology Department, Jiangxi [20171BAB205008] No other disclosures were reported. Ethics Approval Statement: The parent study (the CSPPT) was approved by the Ethics Committee of the Institute of Biomedicine, Anhui Medical University, Hefei, China (Federal-wide Assurance Number: FW1263). All participants provided written, informed consent.
Read full abstract