prediabetes
Conditions
Interventions
vitamin D+ placebo group:supplement with vitamin D (1600 IU/day) and calcium-matched placebo for 24 weeks
calcium + placebo group:supplement with calcium (500mg/day) and vitamin D-matched placebo for 24 weeks
vitamin D+calcium group:supplement with vitamin D (1600 IU/day) and calcium (500mg/day) for 24 weeks
placebo + placebo group:supplement with identical looking placebo for 24 weeks
Sponsors
Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Individuals with prediabetes, which is defined by fasting serum glucose of 5.6-6.9 mmom/L and (or) 2-hour serum glucose of 7.8-11.0 mmom/L; (2) Adult people between 18 and 70 years of age; (3) Individuals who signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Meeting the diagnosis criteria for type 2 diabetes or having history of physician diagnosed type 2 diabetes or taking anti-diabetes medication; (2) Having history of unstable angina, myocardial infarction, or stroke in the past 1 year; (3) Having uncontrolled treated/untreated hypertension (systolic blood pressure>=160 mmHg and/or diastolic blood pressure >=100 mmHg); (4) Having history of any type of cancer in the past 5 years; (5) Having history of liver disease (such as severe fatty liver, cirrhosis, liver abscess, hepatitis, etc.), or history of kidney disease (such as kidney stone, nephritis, ureteral stone, etc.), or active tuberculosis; (6) Having history of hyperparathyroidism in the past 3 years; (7) Current use of medications such as antiepileptics, anticonvulsants, oral or intravenous corticosteroids; (8) Current pregnancy or breastfeeding; (9) Hypercalcemia (defined as serum total calcium >2.75 mmol/L or ionized s-calcium >1.37 mmol/L) or hypercalciuria (defined as fasting urine calcium-creatinine ratio > 0.275); (10) Impaired hepatic function, defined as alanine aminotransferase (ALT) twice or more than the upper reference limit (40 U/L); (11) Impaired renal function, defined as s-creatinine >133 umol/L for males and >115 umol/L for females; (12) Taking vitamin D or calcium supplementation currently; (13) Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pancreatic beta cell function (disposition index); | — |
Secondary
| Measure | Time frame |
|---|---|
| insulin sensitivity;fasting plasma glucose;HbAIc;25(OH)D;insulin resistance;lipid profiles (TC, TG, HDL-c, LDL-c);2h post-load plasma glucose; | — |
Countries
China
Contacts
Public ContactWenjie Li
Zhengzhou University
Outcome results
None listed