Active vitamin D treatment and Prevention of Sarcopenia in Adults with Prediabetes
- Conditions
- Sarcopenia, Prediabetes, Diabetes Mellitus
- Registration Number
- JPRN-UMIN000005394
- Lead Sponsor
- niversity of Occupational and Environmental Health Kokura Medical Association, Health Testing Center Fujisawa City Hospital Shin Komonji Hospital
- Brief Summary
During a median follow-up of 2.9 years, 79 (12.5%) of 630 participants in the eldecalcitol group and 89 (14.2%) of 626 in the placebo group developed type 2 diabetes (HR 0.87, 95%CI 0.67 to 1.17, P=0.39). After adjustment for confounding factors by multivariable fractional polynomial Cox regression analysis, eldecalcitol significantly lowered the development of diabetes (HR 0.69, 0.51 to 0.95, P=0.020).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 1256
Not provided
1. Individuals who have participated in other clinical trials. 2. Individuals who have been treated with active vitamin D, vitamin D supplement, and/or calcium preparation within the preceding 3-month period. 3. Individuals who have already been diagnosed with type 1, type 2 diabetes, and/or sarcopenia. 4. Individuals in whom drug treatment for prediabetes has been initiated. 5. Individuals who are pregnant or have severe diseases, such as renal insufficiency (serum creatinine of 1.5 mg/dl or higher), hepatic insufficiency, psychosis, collagen diseases, heart diseases, and cerebrovascular diseases. 6. A sub investigator may preclude participant involvement in the study based on screening and assessment of the participants condition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method