Association of Cystatin C and Bone Mineral Density in Diabetic Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum Cystatin C
研究概览
简要总结
Type 1 diabetes is associated with low bone mineral density(BMD) and type 2 diabetes with normal or high BMD.
Cystatin C is a small molecule that is used to measure kidney function but it's not a troponin of the kidney. It has been associated with many other diseases like atrial fibrillation, depressive symptoms, melanoma, etc.
This crossectional clinical study was done to evaluate the association between Cystatin C and Bone mineral density in both types of diabetic patients.
详细描述
This is a cross-sectional study of adults with diabetes to determine the association of cystatin C with bone mineral density(BMD). All the inpatient in the department of endocrinology and metabolism in the fifth affiliated hospital of Sun Yat-Sen University will be screened for 5 to 6 months. Those satisfying the inclusion and exclusion criteria will be included in the study after signing the informed consent.
The patient's blood will be withdrawn in the morning after 8 hours of fasting and sent to the laboratory of the hospital for blood lipids, Hba1c, urinary Albumin creatinine ratio, uric acid, GGT, vitamin D, calcium, cystatin C, βserum collagen type 1 cross-linked C-telopeptide(βCTX),procollagen type I N-terminal propeptide( P1NP), phosphorus, alkaline phosphatase. Smoking habits, duration of diabetes, diabetes medications, and fracture history will be asked. The history of smoking is classified as
- Non-smokers: Subjects who have never smoked any products (cigarettes, pipes or cigars) during their lifetime;
- Smoking cessation: a person who smokes one or more products but stops smoking at least one month prior to the baseline survey;
- Current smokers: A subject or any other product that smokes at least one cigarette per day.
The pelvic BMD, Vertebral body BMD will be measured in the physical examination department of the hospital and divided into normal, osteopenia, osteoporosis.
All covariates will be extracted to SPSS v.23 for statistical analysis to evaluate the association of Cystatin C and BMD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes male / female, older than 50 years old.
排除标准
- •Use of any drug that affects bone metabolism (bisphosphonate, denosumab, teriparatide, steroids, anticancer drugs, thyroid hormones, antidepressants, antiretrovirals, calcium, vitamins A/D)
- •Any disease affecting bone minerals (hyperthyroidism, hypothyroidism, parathyroid disease, Cushing's disease, rickets/osteomalacia, collagen disorders, rheumatoid arthritis)
- •Kidney disease, urinary albumin-creatinine ratio greater than 30 mg / g or GFR <60ml / min / 1.73m2.
结局指标
主要结局
Serum Cystatin C
时间窗: 6 months
It is measured as a part of routine investigation at the time of admission
次要结局
- Bone mineral density(6 months)
研究者
XiaoChun Shu
Chief Physician
Fifth Affiliated Hospital, Sun Yat-Sen University