OsteoporosisNCT04019938
Association of Cystatin C and Bone Mineral Density in Diabetic Patients.
An observational study of Osteoporosis and Osteoporosis, Postmenopausal, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Osteoporosis, Postmenopausal, Diabetes Mellitus
- What is being tested?
- Dual-energy X-ray absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2019to 25 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient in the department of endocrinology and metabolism in the fifth affiliated hospital of Sun Yat-Sen University.
Who may be able to join
- Type 1 or type 2 diabetes male / female, older than 50 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ashish Shrestha
Zhuhai, Guangdong, 15000
Ashish Shrestha, 13246822232, ashishshrestha@outlook.com
About this study
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.
Read the 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.
- Being tested
- Dual-energy X-ray absorptiometry
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy X-ray absorptiometryRadiation
Cystatin C is measured as a part of routine investigation at the time of admission.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic adults | Not described Receives: Radiation: Dual-energy X-ray absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Cystatin C
It is measured as a part of routine investigation at the time of admission
Measured: 6 months
Secondary outcomes (1)
Bone mineral density
Bone mineral density is measured using the Dual-energy X-ray absorptiometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start4 Jul 2019
- Primary completion25 Dec 2019 (estimated)
- Study completion25 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoChun Shu, Fifth Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xiao Chun Shu, Principal investigator, Fifth affiliated hospital of Sun Yat-Sen UniversityAshish Shrestha, Principal investigator, Fifth affiliated hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019938
- Sponsor's protocol ID
- ZDWY(2019) K12-1
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cystatin C and Bone Mineral Density in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT04019938
- Acronym / sponsor ID
- ZDWY(2019) K12-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 25 Dec 2019 (estimated)
- Study completion
- 25 Dec 2019 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic adults | – | Radiation: Dual-energy X-ray absorptiometry |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient in the department of endocrinology and metabolism in the fifth affiliated hospital of Sun Yat-Sen University.
Key inclusion criteria (1 listed)
- Type 1 or type 2 diabetes male / female, older than 50 years old.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy X-ray absorptiometryCystatin C is measured as a part of routine investigation at the time of admission. | Radiation | Diabetic adults |
Primary outcome
Serum Cystatin C
Time frame: 6 months
It is measured as a part of routine investigation at the time of admission
1 secondary outcome
Bone mineral density
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao Chun Shu principal investigator
Fifth affiliated hospital of Sun Yat-Sen University
Ashish Shrestha principal investigator
Fifth affiliated hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteoporosis, Postmenopausal, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Chun Shu (13246822232 ext. 0086, zhshuxc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Cystatin C (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.