Clinical trial NCT03952819: The Effects of Hemodialysis on Serum Sclerostin Levels
Official title: The Effects of Hemodialysis on Serum Sclerostin Levels in Diabetic Patients With Chronic Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Renal Failure
Hemodialysis Access Failure
Keywords: Diabetes Mellitus
Renal Failure
Hemodialysis Access Failure
Sclerostin
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 56
Sex: ALL
Minimum age (years): 44
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: change from levels of serum sclerostin of Diabetic group in dialysis at 1 months
timeFrame: blood samples were obtained within 30 minutes of before and after dialysis
measure: change from levels of serum sclerostin of Non-diabetic group in dialysis at 1 months
timeFrame: blood samples were obtained within 30 minutes of before and after dialysis
measure: change from levels of serum sclerostin of control group
timeFrame: through study completion, an average of 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: BAİBÜ
name: Ozgur M. Yis
role: STUDY_DIRECTOR
References: