Table 2.
Participant flow of enrolment, intervention, and outcome measurements.
| PS | M0 | M1 | M2 | M3 | ||
|---|---|---|---|---|---|---|
| Enrolment | Recruitment | √ | ||||
| Eligibility Screening | √ | |||||
| Signed written informed consent | √ | |||||
| Allocation | √ | |||||
| Intervention | Health education, medical nutrition therapy, exercise therapy, self-monitoring of blood glucose, and disease follow-up | √ | √ | √ | √ | |
| High-dose vitamin D2 /placebo injection | √ | √ | √ | |||
| Outcomes | Demographic characteristics and basic information (sex, age, marital status, place of residence, and education level) | √ | ||||
| Personal life status (smoking status, drinking status, beverage intake status, sunshine reception, living alone, and menstrual status for females) | √ | |||||
| Duration of diabetes, strict diet control, and moderate aerobic exercise for >150 min per week | √ | |||||
| Number of self-monitoring of blood glucose per week and occurrence of hypoglycemia | √ | |||||
| Comorbidities (hypertension, hyperuricemia, obesity, osteoporosis, and nonalcoholic fatty liver disease) | √ | |||||
| Other diabetic complications (diabetic retinopathy, diabetic nephropathy, diabetic foot ulcer, coronary atherosclerotic heart disease, cerebrovascular disease, and peripheral vascular disease) | √ | |||||
| Anthropometric measurements (height, weight, body mass index, waist, and hip circumference) and blood pressure (systolic and diastolic blood pressure) | √ | √ | ||||
| Metabolic parameters (FBG, 2hBG, HbA1C, FCP, 2hCP, triglycerides, total cholesterol, HDL-C, LDL-C, uric acid, HOMA2-IR/%S/%B) | √ | √ | ||||
| Intima-media thickness of carotid and dorsalis pedis artery by ultrasound, fundus examination, bone mineral density | √ | √ | ||||
| 25-(OH) Vitamin D2, 25-(OH) Vitamin D3, and 25-(OH) Vitamin D tested by LC-MS/MS method | √ | √ | ||||
| Maximum bimanual grip strength measured by a dynamometer | √ | √ | ||||
| Short Form -12 Quality of Life Questionnaire | √ | √ | ||||
| MNSI score | √ | √ |
PS, prior to study; M0, baseline assessment; M1, 1 month from baseline; M2, 2 months from baseline; M3, 3 months from baseline; HOMA2-IR/%S/%B; homeostasis model assessment index 2 for assessing insulin resistance/insulin sensitivity/function of islet β-cells; LC-MS/MS, liquid chromatography-tandem mass spectrometry; *MNSI, Michigan Neuropathy Screening Instrument; FBG, fasting blood glucose; HbA1c, hemoglobin A1c; 2hBG, 2-h postprandial blood glucose; FCP, fasting C-peptide; 2hCP, 2-h postprandial C-peptide; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol.