Pre-diabetes
Conditions
Interventions
Elderly population with pre-diabetes:None
Intervention group:Using vitamin D3 supplements
Control group:Placebo
Sponsors
National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the first part: From 2022 to 2024, among the elderly who participated in health examinations for three consecutive years and have complete relevant information (age, waist circumference, BMI, Hb, education level, smoking, drinking status), lipid indicators (serum total cholesterol, HDL, LDL, TG), blood glucose indicators (fasting blood glucose), and blood pressure indicators (SBP, DBP), the diagnosis of prediabetes was made using FPG and HbA1c tests according to the currently internationally accepted ADA (2025) standards: (1) Impaired fasting glucose (IFG): 5.6 <= FPG < 7.0 mmol/L; (2) Glycated hemoglobin (HbA1c): 5.7% <= HbA1c < 6.5% (meeting either criterion). Inclusion criteria for the second part: (1) Ages 65-80, BMI 20-26.9 kg/m^2, in generally good condition, able to live independently; (2) Serum 25(OH)D level < 12 ng/ml; (3) Combined with OGTT tests, using the American Diabetes Association (ADA) 2025 standards for diagnosing prediabetes (meeting any one criterion can be diagnosed as pre-DM): a. Impaired fasting glucose (IFG): 5.6 <= FPG < 7.0 mmol/L; b. Abnormal glucose tolerance (IGT): FPG < 7.0 mmol/L; 7.8 <= PP2h < 11.0 mmol/L; c. Abnormal glycated hemoglobin: 5.7% <= HbA1c < 6.5%. * Note: IFG and IGT are collectively referred to as impaired glucose regulation (IGR).
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for the first part: Exclude populations diagnosed with T2D. 2. Exclusion criteria for the second part: (1) Newly diagnosed or self-reported diabetes (FPG >= 7.0 mmol/L and/or 2h-PG >= 11.1 mmol/L and/or ongoing hypoglycemic treatment); (2) A history of severe symptoms of cardiovascular disease in the past year (such as unstable angina, myocardial infarction, or stroke); (3) Impaired liver or kidney function; (4) Bone changes (such as hyperthyroidism, kidney stones, and granulomatous disease); (5) Hypercalcemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-h postprandial plasma glucose;Vitamin D;Glycatedhemoglobin;Fasting insulin;Fasting blood glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone mineral density;Bone turnover markers, inflammatory factors, adipokines, and oxidative stress indicators;Parathyroid hormone; | — |
Countries
China
Contacts
Public ContactLichen Yang
National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention
Outcome results
None listed