NCT04019938

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 11, 2019

Last Update Submit

July 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum Cystatin C

    It is measured as a part of routine investigation at the time of admission

    6 months

Secondary Outcomes (1)

  • Bone mineral density

    6 months

Study Arms (1)

Diabetic adults

Radiation: Dual-energy X-ray absorptiometry

Interventions

Cystatin C is measured as a part of routine investigation at the time of admission.

Diabetic adults

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashish Shrestha

Zhuhai, Guangdong, 15000, China

RECRUITING

MeSH Terms

Conditions

OsteoporosisOsteoporosis, PostmenopausalDiabetes Mellitus

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Xiao Chun Shu

    Fifth affiliated hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR
  • Ashish Shrestha

    Fifth affiliated hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 15, 2019

Study Start

July 4, 2019

Primary Completion

December 25, 2019

Study Completion

December 25, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations