An observational study in Diabetes Mellitus, Renal Failure and Hemodialysis Access Failure, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 44 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by Abant Izzet Baysal University · Observational
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.
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.
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This study's enrollment of 56 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.
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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.
Exclusion Criteria:
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
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
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
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).
Time frame: 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).
Time frame: 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).
Time frame: through study completion, an average of 1 day.
Plan to share: No
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Abant Izzet Baysal University