Patients with and without DM at Shiga University of Medical Science (SUMS) Hospital, Shiga, Japan were invited to participate in this study. Before we checked patients’ eligibility, we screened them by analyzing the distribution of age, body mass index (BMI), sex, glycated hemoglobin (HbA1c) level, and treatment regimen in patients with DM (DM group), and the distribution of age, BMI, and sex in patients without DM (non-DM group), among all patients who visited the outpatient clinic of our endocrinology department from August 2016 to May 2017. The inclusion criteria for the DM group were as follows: outpatients with type 2 DM, age 60–79 years, and BMI of 18 to <35 kg/m2. The inclusion criteria for the non-DM group were as follows: outpatients who were visiting the SUMS Hospital for dyslipidemia, hypertension, and obesity; age 60–79 years; and BMI of 18 to <35 kg/m2. The non-DM group comprised patients without diabetic medications and without past or current DM, or with an HbA1c level of <6.0% within 1 year. The exclusion criteria are presented in online supplementary information 1.
bmjdrc-2019-000648supp001.docx
The DM group comprised three subgroups of patients: those with DM treated by insulin (DM-Insulin), DM treated by oral antidiabetic drugs (OADs) (DM-OAD), and DM treated by diet (DM-Diet). Each group had a 1:1 sex ratio and an HbA1c distribution similar to that of each treatment population at the SUMS Hospital. The non-DM group also had a 1:1 sex ratio and a BMI distribution similar to that of the DM group. The nature and potential risks of the study were explained to all participants, and written informed consent was obtained. The study is registered at UMIN Clinical Trials Registry (http://www.umin.ac.jp/ctr/index.htm).
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