The Effects of Hemodialysis on Serum Sclerostin Levels (sclerostin)

May 14, 2019 updated by: Ozgur Mehmet Yis, Abant Izzet Baysal University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Bolu, Merkez, Turkey, 14100
        • Bolu Abant İzzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

44 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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).
blood samples were obtained within 30 minutes of before and after dialysis
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).
through study completion, an average of 1 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Study Director: Ozgur M. Yis, BAİBÜ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2017

Primary Completion (ACTUAL)

November 15, 2018

Study Completion (ACTUAL)

December 15, 2018

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (ACTUAL)

May 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AbantIBU-Biochem-OMY-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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