This retrospective cohort study included outpatients and inpatients from January 2016 to December 2020. T2DM patients with pre-hypertension were recruited. We defined T2DM as fasting plasma glucose (FPG) ≥7.00 mmol/L or self-reported receipt of antidiabetic treatment . Pre-hypertension was defined as SBP/DBP of 120-139/80-89 mm Hg, in participants without a history of hypertension and use of antihypertensive medication . The exclusion criteria were: no available information on characteristics; no available HbA1C value and glucose value; participants diagnosed with hypertension or other CVDs at baseline and participants with undefined CVDs status at follow-up; visit intervals < 1 years; and lost to follow-up. Cohort entry was defined as the date of the initial visit between January and December 2016, and follows them up until December 2020.
Clinical data (including demographic characteristics, lifestyle, medical history and family history of hypertension and CVDs) and results of laboratory test (including blood glucose, blood lipids, etc) were collected from an electronic clinical information system at baseline or collected through a structured interview.
All patients underwent biochemistry examination were performed on an auto analyzer (Beckman 5800), including fasting plasma glucose (FPG), triglycerides, total cholesterol, high density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), serum creatinine (Scr), and alanine aminotransferase (ALT).
Exposure of interest
PA was evaluated by patients themselves. The evaluated standard based on the American Diabetes Association Standards for Diabetes Care 2014 : adults with diabetes should be advised to perform at least 150 minutes per week of moderate-intensity aerobic physical activity (50–70% of maximum heart rate), spread over at least 3 days per week with no more than 2 consecutive days without exercise; In the absence of contraindications, adults with type 2 diabetes should be encouraged to perform resistance training at least twice each week . All patients were took exercise evaluation at initial visit. Subjects who did not meet the above conditions were classified as physical inactivity (PIA) group; on the contrary, as PA group.
Outcome measures and follow-up
The outcomes of interest were incident of new-onset hypertension and other CVDs complications during follow-up period. All subjects participated in physical examinations every year and they would see a doctor in our hospital if there was any discomfort. In addition, almost every surviving patient accepted follow-up for blood pressure and other examinations every 3 months for new-onset hypertension, and other CVDs from the electronic clinical information system in December of each year until 2020.
New hypertension and CVDs were recorded in all patients. Hypertension was defined as either systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg or self-reported receipt of antihypertensive treatment . The CVDs included femoral/carotid atherosclerosis (AS), coronary AS, cerebral ischemic focus, CHD, percutaneous coronary intervention (PCI), and coronary artery bypass graft. Blood pressure value was obtained by trained staff using standard mercury sphygmomanometers through office blood pressure measurements. Femoral/carotid AS was diagnosed by vascular B-ultrasound. Coronary AS and CHD were diagnosed by coronary computed tomography angiography (CTA) or coronary angiography. Cerebral ischemic focus diagnosed by head computed tomography scans (CT) or nuclear magnetic resonance imaging (MRI).
Covariates of interest included age, gender, BMI, FPG, triglycerides, total cholesterol, HDL-C, LDL-C, ALT, smoking status, drinking status, family history of hypertension. As for participants’ personal habits, participants were classified by smoking status into current smokers or not. Current smoker was defined as having a current smoking habit regardless of the number of cigarettes smoked per day, and habitual drinker was defined as consuming ≥150 g of alcohol per week.
Evaluation of normality was performed with Shapiro-Wilk test. Continuous variables were expressed as the means ±standard deviations (normal distribution), and categorical variables were expressed as frequency or percentages. Independent-samples T test was used for normally distributed continuous variables, Mann-Whitney U test for non-normally distributed continuous variables, and chi-square tests for categorical variables. Missing continuous variables were mainly supplemented by means or median. We evaluated the unadjusted and adjusted ORs of incident hypertension using univariate and multivariate logistic regression analyses.
The ethics committee of Zhejiang Hospital approval
The study was approved by the ethics committee of Zhejiang Hospital (No. 2022-39K). The data are anonymous, and the requirement for informed consent was therefore waived by the ethics committee of Zhejiang Hospital. Correspondence and requests for data should be addressed to Q.Wu.
Statement of human right
All research procedures in this study involving human participates were performed according to the ethical standards of the Zhejiang hospital and/or national research committee and the criteria of the declaration of Helsinki (1964) and its later amendment or comparable ethical standards.
The datasets generated and/or analyzed during the current study are not publicly available due the restrictions apply to the availability of these data, but are available from the corresponding author on reasonable request.