Type 2 diabetes
Conditions
Interventions
Group oral :Calcitriol capsules 0.25ug p.o. bid for 48 weeks
Group low dose of injection:Vitamin D3 Injection 300,000 u intramuscularly every 8 weeks for 48 weeks
Group high dose of injection:Vitamin D3 Injection 600,000 u intramuscularly every 8 weeks for 48 weeks
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years when signing the Informed Consent Form (ICD); 2. According to WHO standards, T2DM has been diagnosed in the past for at least 6 months; 3. Complete metabolic surgery; 4. 25 OH Vitamin D<20ng/mL; 5. Willing and able to comply with the research process of the program; 6. Be able to understand and sign the study informed consent, if it is illiterate, willing to make a handprinting on the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients known to be allergic to calcitriol capsules or vitamin D3 injections or similar drugs and any of their excipients; 2. History of drug and/or alcohol abuse within 2 years before the screening visit; 3. Hypercalcemia (blood calcium greater than 2.75 mmol/) or 25 OH vitamin D = 20 ng/mL; 4. Women of childbearing age who are pregnant or lactating during screening or surgery, or plan to become pregnant within one year after surgery; 5. Mental illnesses that may affect clinical research compliance, including dementia, active psychosis, major depression, or attempted suicide; 6. Meets any of the following conditions: (1) Inflammatory diseases of the gastrointestinal tract, including severe refractory esophagitis, gastric ulcer, duodenal ulcer, or specific inflammation that has been active during the past 10 years, such as Crohn's disease or ulcerative colitis; (2) End-stage renal disease; (3) Abnormality of glutamic acid decarboxylase antibody (GADA), protein tyrosine phosphatase antibody (IA-2A); or (4) Poor immune function, for example caused by long-term oral steroids, cancer chemotherapy drugs, or immunodeficiency diseases; 7. Participate in any other clinical study (other than registration or survey research) within 30 days of visit 1 (screening visit) or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| parathyroid hormone;25 OH vitamin D;bone mineral density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events;Medication; | — |
Countries
China
Contacts
Public ContactYuqian Bao
Outcome results
None listed