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NCT Number: NCT03952819

The Effects of Hemodialysis on Serum Sclerostin Levels

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hemodialysis Access Failure Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Failure Renal Insufficiency Sclerosteosis Urogenital Diseases Urologic Diseases

Age range

44 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum sclerostin

Diagnostic Test

blood samples obtained

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Acronym: sclerostin

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 16, 2019
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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