2.5. Outcomes
dizziness, TG, syncope, headedness
ADVERSE EVENTS, SECONDARY, INSULIN RESISTANCE, BLOOD, INSULIN SENSITIVITY
The primary outcomes were FPG and HbA1c levels measured at 12 weeks after randomization. Secondary outcomes included body weight, SBP, DBP, fasting insulin, TG, total cholesterol, LDL-C, HDL-C, and hs-CRP. The homeostatic model assessment of insulin resistance (HOMA-IR) was calculated by multiplying the fasting insulin (mIU/L) with FPG (mg/dL) and dividing by 405 to measure insulin sensitivity in the participants. FPG was measured using hexokinase glucose-6 phosphate dehydrogenase. HbA1c levels were measured using the turbid metric inhibition immunoassay certified by the National Glycohemoglobin Standardization Program. Serum triglyceride was measured by lipase/glycerol kinase glycerol-3-phosphate oxidase. HDL-C and LDL-C levels were measured by the accelerator selective detergent method. Chemiluminescence and nephelometry methods were used for measuring fasting insulin and hs-CRP, respectively. Body weight was measured without shoes to the nearest 100 g using a Seca 284 Wireless Measuring Station—Weight & Height 2841300109. Blood pressure was measured by the Connex Spot Monitor; Welch Allyn, Inc. (Auburn, NY, USA) with an automatic blood pressure cuff after resting for at least 15 min. Body weight and blood pressure were measured by trained research assistants.All primary and secondary outcomes were assessed at baseline and weeks 4, 8, and 12 after randomization. Possible adverse events of TRE, such as syncope, dizziness, and light headedness, were monitored and recorded throughout the study period.