- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04019938
Association of Cystatin C and Bone Mineral Density in Diabetic Patients.
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.
Study Overview
Status
Intervention / Treatment
Detailed 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The patient's blood will be withdrawn in the morning after 8 hours of fasting and sent to the laboratory of the hospital for blood lipids, Hba1c, urinary Albumin creatinine ratio, uric acid, GGT,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
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Guangdong
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Zhuhai, Guangdong, China, 15000
- Recruiting
- Ashish Shrestha
-
Contact:
- Ashish Shrestha
- Phone Number: 13246822232
- Email: ashishshrestha@outlook.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Diabetic adults
|
Cystatin C is measured as a part of routine investigation at the time of admission.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Cystatin C
Time Frame: 6 months
|
It is measured as a part of routine investigation at the time of admission
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone mineral density
Time Frame: 6 months
|
Bone mineral density is measured using the Dual-energy X-ray absorptiometry
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Xiao Chun Shu, Fifth Affiliated Hospital of Sun Yat-sen University
- Principal Investigator: Ashish Shrestha, Fifth Affiliated Hospital of Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZDWY(2019) K12-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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