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The Effects of Hemodialysis on Serum Sclerostin Levels (sclerostin)

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ClinicalTrials.gov Identifier: NCT03952819
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ozgur Mehmet Yis, Abant Izzet Baysal University

Brief 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. 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.


Condition or disease Intervention/treatment
Diabetes Mellitus Renal Failure Hemodialysis Access Failure Diagnostic Test: serum sclerostin

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.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effects of Hemodialysis on Serum Sclerostin Levels in Diabetic Patients With Chronic Renal Failure
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
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.
Diagnostic Test: serum sclerostin
blood samples obtained

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.
Diagnostic Test: serum sclerostin
blood samples obtained

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.
Diagnostic Test: serum sclerostin
blood samples obtained




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



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Ages Eligible for Study:   44 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952819


Locations
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Turkey
Bolu Abant Izzet Baysal University
Bolu, Merkez, Turkey, 14100
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Study Director: Ozgur M. Yis BAİBÜ

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Responsible Party: Ozgur Mehmet Yis, Assist. Prof., Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT03952819     History of Changes
Other Study ID Numbers: AbantIBU-Biochem-OMY-1
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ozgur Mehmet Yis, Abant Izzet Baysal University:
Diabetes Mellitus
Renal Failure
Hemodialysis Access Failure
Sclerostin

Additional relevant MeSH terms:
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Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases