The Effects of Hemodialysis on Serum Sclerostin Levels

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Hemodialysis on Serum Sclerostin Levels in Diabetic Patients With Chronic Renal Failure

Conditions
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Diabetes Mellitus, Renal Failure, Hemodialysis Access Failure

Intervention / Treatment
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* Diagnostic Test: serum sclerostin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 44 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic group,<br>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<br>* blood samples obtained<br>|
| Non-Diabetic group,<br>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<br>* blood samples obtained<br>|
| Control group,<br>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<br>* blood samples obtained<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | through study completion, an average of 1 day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Renal Failure, Hemodialysis Access Failure, Sclerostin