Diabetes MellitussclerostinNCT03952819
The Effects of Hemodialysis on Serum Sclerostin Levels
An observational study of Diabetes Mellitus and Renal Failure, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Background: Parathyroid hormone (PTH) and 1,25-dihydroxy vitamin D (1,25-OHD) as well as mineral bone metabolism modulators like sclerostin are thought to play an important role in in diabetic patients with chronic renal failure. Read more about this study
- Who is it for?
- Ages 44 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Renal Failure, Hemodialysis Access Failure
- What is being tested?
- serum sclerostin
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2017to 15 Dec 2018
- 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 44 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study was designed with 56 individuals; 28 chronic hemodialysis patients (17 men, 11 women) receiving treatment at our hospital and 28 healthy volunteers as a control group. Of the 28 hemodialysis patients, 14 had Type 2 diabetes mellitus while the other 14 were not diabetic.
Who may be able to join
- Patients who satisfied inclusion criteria signed informed consent forms before they enrolled in the study.
- Chronic hemodialysis patients receiving treatment at our hospital.
- The patients had Type 2 diabetes mellitus and the patients were not diabetic.
- Healthy volunteers as a control group
Who cannot join
- Clinical diagnosis of chronic respiratory failure, acute kidney failure, nephrotic syndrome, end-stage liver disease, malignancy, acute infections
- Any health problems necessitating urgent interventions, drinking alcohol and/or smoking as well as pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: The Effects of Hemodialysis on Serum Sclerostin Levels in Diabetic Patients With Chronic Renal Failure
Background: Parathyroid hormone (PTH) and 1,25-dihydroxy vitamin D (1,25-OHD) as well as mineral bone metabolism modulators like sclerostin are thought to play an important role in in diabetic patients with chronic renal failure. The present study aimed to analyse the levels of serum sclerostin before and after hemodialysis which is a primary element of treatment in such combined disease states.
Methods: Serum sclerostin concentrations were measured using a commercially available enzyme-linked immunosorbent assay kit with 56 individuals who 14 chronic hemodialysis patients with diabetes, 14 chronic hemodialysis patients with non-diabetes and 28 healthy volunteers as a control group.
Read the detailed description
Sclerostin results in a phenotype characterized by high bone mass (sclerosteosis) in humans, it is produced by osteocytes and chondrocytes, it suppresses osteoblast activity by inhibiting canonicular Wnt / β-catenin signal, it is described as an anti-anabolic protein of 22-kDa size.In diabetes mellitus patients osteoporosis and obesity always create problems, increased levels of sclerostin inhibit canonicular Wnt / β-catenin signal and is potentially held responsible from bone fragility. Bone problems are important both for chronic kidney disease patients and diabetes mellitus patients and in instances where these two diseases coexist, the importance of sclerostin as a new marker of bone turnover increases. The objective of this study is to evaluate how serum sclerostin levels are affected in diabetes mellitus patients undergoing hemodialysis treatment. To this end, the investigators analyzed the levels of serum sclerostin before and after hemodialysis as it is a main element of treatment in such combined disease states.
- Being tested
- serum sclerostin
- Keywords
- Diabetes Mellitus, Renal Failure, Hemodialysis Access Failure, Sclerostin
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sclerostinDiagnostic test
blood samples obtained
| Study group | Role | What they receive |
|---|---|---|
| Diabetic group, | The study was designed with 28 chronic hemodialysis patients (17 men, 11 women) receiving treatment at our hospital. Of the 28 hemodialysis patients, 14 had Type 2 diabetes mellitus. On the day of hemodialysis, blood samples were obtained within 30 minutes of before and after dialysis. Intervention is to take blood samples and determine serum sclerostin level in blood samples. Any drugs or substances will not be given. Receives: Diagnostic Test: serum sclerostin | |
| Non-Diabetic group, | Of the 28 hemodialysis patients, the other 14 were not diabetic. On the day of hemodialysis, blood samples were obtained within 30 minutes of before and after dialysis. Intervention is to take blood samples and determine serum sclerostin level in blood samples. Any drugs or substances will not be given. Receives: Diagnostic Test: serum sclerostin | |
| Control group, | The study was designed with 56 individuals; 28 healthy volunteers as a control group. Venous blood samples of the control group were obtained at the blood sampling unit by the healthcare personnel during morning hours following overnight fasting while they were sitting after being rested. The intervention is to take blood samples and determine serum sclerostin level in blood samples. Any drugs or substances will not be given. Receives: Diagnostic Test: serum sclerostin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from levels of serum sclerostin of Diabetic group in dialysis at 1 months
Sclerostin is an anti-anabolic protein of 22-kDa size, at a level of ng/mL. Serum concentrations are measured with an ELISA kit (Cloud-CloneCorp., Katy, TX 77494, USA).
Measured: blood samples were obtained within 30 minutes of before and after dialysis
change from levels of serum sclerostin of Non-diabetic group in dialysis at 1 months
Sclerostin is an anti-anabolic protein of 22-kDa size, at a level of ng/mL. Serum concentrations are measured with an ELISA kit (Cloud-CloneCorp., Katy, TX 77494, USA).
Measured: blood samples were obtained within 30 minutes of before and after dialysis
change from levels of serum sclerostin of control group
Sclerostin is an anti-anabolic protein of 22-kDa size, at a level of ng/mL. Serum concentrations are measured with an ELISA kit (Cloud-CloneCorp., Katy, TX 77494, USA).
Measured: through study completion, an average of 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start14 Sep 2017
- Primary completion15 Nov 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Mehmet Yis, Abant Izzet Baysal University
- Investigators
- Ozgur M. Yis, Study director, BAİBÜ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952819
- Sponsor's protocol ID
- AbantIBU-Biochem-OMY-1
- Acronym
- sclerostin
- Status last verified
- May 2019
- First submitted
- 31 Jan 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hemodialysis on Serum Sclerostin Levels in Diabetic Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT03952819
- Acronym / sponsor ID
- sclerostin / AbantIBU-Biochem-OMY-1
- Keywords
- Diabetes Mellitus, Renal Failure, Hemodialysis Access Failure, Sclerostin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 16 May 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.
Background: Parathyroid hormone (PTH) and 1,25-dihydroxy vitamin D (1,25-OHD) as well as mineral bone metabolism modulators like sclerostin are thought to play an important role in in diabetic patients with chronic renal failure. The present study aimed to analyse the levels of serum sclerostin before and after hemodialysis which is a primary element of treatment in such combined disease states.
Methods: Serum sclerostin concentrations were measured using a commercially available enzyme-linked immunosorbent assay kit with 56 individuals who 14 chronic hemodialysis patients with diabetes, 14 chronic hemodialysis patients with non-diabetes and 28 healthy volunteers as a control group.
Detailed description
Sclerostin results in a phenotype characterized by high bone mass (sclerosteosis) in humans, it is produced by osteocytes and chondrocytes, it suppresses osteoblast activity by inhibiting canonicular Wnt / β-catenin signal, it is described as an anti-anabolic protein of 22-kDa size.In diabetes mellitus patients osteoporosis and obesity always create problems, increased levels of sclerostin inhibit canonicular Wnt / β-catenin signal and is potentially held responsible from bone fragility. Bone problems are important both for chronic kidney disease patients and diabetes mellitus patients and in instances where these two diseases coexist, the importance of sclerostin as a new marker of bone turnover increases. The objective of this study is to evaluate how serum sclerostin levels are affected in diabetes mellitus patients undergoing hemodialysis treatment. To this end, the investigators analyzed the levels of serum sclerostin before and after hemodialysis as it is a main element of treatment in such combined disease states.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic group, | – | Diagnostic Test: serum sclerostinThe study was designed with 28 chronic hemodialysis patients (17 men, 11 women) receiving treatment at our hospital. Of the 28 hemodialysis patients, 14 had Type 2 diabetes mellitus. On the day of hemodialysis, blood samples were obtained within 30 minutes of before and after dialysis. Intervention is to take blood samples and determine serum sclerostin level in blood samples. Any drugs or substances will not be given. |
| Non-Diabetic group, | – | Diagnostic Test: serum sclerostinOf the 28 hemodialysis patients, the other 14 were not diabetic. On the day of hemodialysis, blood samples were obtained within 30 minutes of before and after dialysis. Intervention is to take blood samples and determine serum sclerostin level in blood samples. Any drugs or substances will not be given. |
| Control group, | – | Diagnostic Test: serum sclerostinThe study was designed with 56 individuals; 28 healthy volunteers as a control group. Venous blood samples of the control group were obtained at the blood sampling unit by the healthcare personnel during morning hours following overnight fasting while they were sitting after being rested. The intervention is to take blood samples and determine serum sclerostin level in blood samples. Any drugs or substances will not be given. |
Who may qualify
- Ages
- 44 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study was designed with 56 individuals; 28 chronic hemodialysis patients (17 men, 11 women) receiving treatment at our hospital and 28 healthy volunteers as a control group. Of the 28 hemodialysis patients, 14 had Type 2 diabetes mellitus while the other 14 were not diabetic.
Key inclusion criteria (4 listed)
- Patients who satisfied inclusion criteria signed informed consent forms before they enrolled in the study.
- Chronic hemodialysis patients receiving treatment at our hospital.
- The patients had Type 2 diabetes mellitus and the patients were not diabetic.
- Healthy volunteers as a control group
Key exclusion criteria (2 listed)
- Clinical diagnosis of chronic respiratory failure, acute kidney failure, nephrotic syndrome, end-stage liver disease, malignancy, acute infections
- Any health problems necessitating urgent interventions, drinking alcohol and/or smoking as well as pregnant patients
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 |
|---|---|---|
| serum sclerostinblood samples obtained | Diagnostic test | Control group,, Diabetic group,, Non-Diabetic group, |
Primary outcome
change from levels of serum sclerostin of Diabetic group in dialysis at 1 months
Time frame: blood samples were obtained within 30 minutes of before and after dialysis
Sclerostin is an anti-anabolic protein of 22-kDa size, at a level of ng/mL. Serum concentrations are measured with an ELISA kit (Cloud-CloneCorp., Katy, TX 77494, USA).
change from levels of serum sclerostin of Non-diabetic group in dialysis at 1 months
Time frame: blood samples were obtained within 30 minutes of before and after dialysis
Sclerostin is an anti-anabolic protein of 22-kDa size, at a level of ng/mL. Serum concentrations are measured with an ELISA kit (Cloud-CloneCorp., Katy, TX 77494, USA).
change from levels of serum sclerostin of control group
Time frame: through study completion, an average of 1 day.
Sclerostin is an anti-anabolic protein of 22-kDa size, at a level of ng/mL. Serum concentrations are measured with an ELISA kit (Cloud-CloneCorp., Katy, TX 77494, USA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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.
Ozgur M. Yis study director
BAİBÜ
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 Diabetes Mellitus and Renal Failure, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 16 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from levels of serum sclerostin of Diabetic group in dialysis at 1 months (time frame: blood samples were obtained within 30 minutes of before and after dialysis). The study lists 3 primary outcomes in all. 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 16 May 2019.