DIABETES MELLITUS
Conditions
Keywords
DIABETES MELLITUS, VITAMIN D, ARTERIAL STIFFNESS, FATTY LIVER, BONE TURNOVER
Brief summary
In many observational studies, vitamin D deficiency is related to glucose intolerance and diabetes. But there little randomized, controlled interventional studies that evaluate the effect of vitamin D in type 2 diabetes. Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2 diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and bone turnover markers.
Detailed description
After informed consent, investigators randomized 180 type 2 diabetes into interventiona group (25-hydroxy vitamin d 2000 IU+ elemental calcium 200mg per day) or placebo group (elemental calcium 200mg per day). The participants should control diabetes by oral medications or lifestyle intervention at the intervention period. Investigators exclude the participants who took vitamin D or calcium or anti-osteoporotic drugs. Investigators also exclude renal insufficiency (Cr\>1.5 in men or Cr\>1.4 in women) or heavy alcoholics. Investigators followed the participants for 24 weeks. After randomization, investigators checked HbA1c,glucose, calcium, 25-hydroxyvitamin d, AST, ALT,Creatinine, Parathyroid hormone, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, and aortic augmentation index, and precontrast liver computed tomography. Also investigators checked body weight, height, and peripheral blood pressure. At 12 weeks, investigators checked HbA1c, 25-hydroxy vitamin D, AST, ALT, calcium, and creatinine. At the end of the study(at 24 weeks), investigators checked HbA1c, glucose, AST, ALT, Creatinine, calcium, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, aortic augmentation index, and precontrast liver computed tomography. After the study completed, investiators compared the data of interventional groups and placebo groups.
Interventions
DRUGVitamin D3
2000IU per day
DRUGplacebo
elemental calcium 200mg per day per 24 weeks
Sponsors
Korean Diabetes Association
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* TYPE 2 DIABETES MELLITUS PATIENTS WHO CONTROL GLUCOSE BY ORAL ANTIBIABETIC DRUGS OR LIFESTYLE ONLY * DID NOT CHANGE ANTIDIABETIC DRUG BEFORE THE STUDY FOR 2 MONTHS * normal physical activity * 30 to 69 years * \>=6.5% OR \<8.0% OF HbA1c
Exclusion criteria
* Creatinine\>1.5 in men, \>1.4 in women * heavy alcoholics * who took calcium or vitamin d or anti-osteoporosis drug within 3 months before the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycemic control | 0, 12week, and 24week | Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| arterial stiffenss | at 0 and 24-week | central blood pressure brachial-ankle pulse wave velocity aortic augmentation index |
Other
| Measure | Time frame | Description |
|---|---|---|
| non-alcoholic fatty liver diseases and bone turnover marker | at 0 and 24- week | precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium |
Countries
South Korea
Outcome results
None listed