Association of Cystatin C and Bone Mineral Density in Diabetic Patients.

Diabetes Mellitus Clinical Trial

Official title:

Association of Cystatin C and Bone Mineral Density in Diabetic Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04019938
• Other study ID #: ZDWY(2019) K12-1
• Status: Recruiting
• Start date: July 4, 2019
• Est. completion date: December 25, 2019

Study information

• Verified date: July 2019
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiao Chun Shu
• Phone: 13246822232
• Email: zhshuxc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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The patient's blood will be withdrawn in the morning after 8 hours of fasting and sent to the laboratory of the hospital for blood lipids, Hba1c, urinary Albumin creatinine ratio, uric acid, GGT,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

1. Non-smokers: Subjects who have never smoked any products (cigarettes, pipes or cigars) during their lifetime;

2. Smoking cessation: a person who smokes one or more products but stops smoking at least one month prior to the baseline survey;

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 25, 2019
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Type 1 or type 2 diabetes male / female, older than 50 years old.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Radiation:
• Dual-energy X-ray absorptiometry
Cystatin C is measured as a part of routine investigation at the time of admission.

Locations

Country	Name	City	State
China	Ashish Shrestha	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Cystatin C	It is measured as a part of routine investigation at the time of admission	6 months
Secondary	Bone mineral density	Bone mineral density is measured using the Dual-energy X-ray absorptiometry	6 months