The Effects of Hemodialysis on Serum Sclerostin Levels

Diabetes Mellitus Clinical Trial

— sclerostin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952819
• Other study ID #: AbantIBU-Biochem-OMY-1
• Status: Completed
• Start date: September 14, 2017
• Est. completion date: December 15, 2018

Study information

• Verified date: May 2019
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 44 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hemodialysis Access Failure
• Renal Failure
• Renal Insufficiency

Intervention

Diagnostic Test:
• serum sclerostin
blood samples obtained

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.