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: Unknown
• Conditions: Diabetes Mellitus; Osteoporosis; Osteoporosis, Postmenopausal
• Intervention / Treatment: Radiation: Dual-energy X-ray absorptiometry

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The patient's blood will be withdrawn in the morning after 8 hours of fasting and sent to the laboratory of the hospital for blood lipids, Hba1c, urinary Albumin creatinine ratio, uric acid, GGT,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

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 15000
      • Recruiting
      • Ashish Shrestha
      • Contact: Ashish Shrestha; Phone Number: 13246822232; Email: ashishshrestha@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatient in the department of endocrinology and metabolism in the fifth affiliated hospital of Sun Yat-Sen University.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic adults	Radiation: Dual-energy X-ray absorptiometry; 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	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	Bone mineral density is measured using the Dual-energy X-ray absorptiometry	6 months

Collaborators and Investigators

• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• 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): July 4, 2019
• Primary Completion (Anticipated): December 25, 2019
• Study Completion (Anticipated): December 25, 2019

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (Actual): July 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: ZDWY(2019) K12-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No