Serum Sclerostin Levels, Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients

NCT01382966 | Unknown DMC

• 1 other identifier: RFM RENAL
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Sclerostin, the product of the SOST gene, located on chromosome 17, locus q11.2 in humans, was originally believed to be a non-classical Bone morphogenetic protein (BMP) antagonist.Sclerostin was recently identified as a component of parathyroid hormone (PTH) signal transduction. Chronic kidney disease (CKD) is associated with abnormalities in bone and mineral metabolism.New advances in the pathogenesis of renal osteodystrophy (ROD) change the perspective from which many of its features and treatment are viewed. Calcium, phosphate, parathyroid hormone (PTH), and vitamin D have been shown to be important determinants of survival associated with kidney diseases. Now ROD dependent and independent of these factors is linked to survival more than just skeletal frailty.Furthermore, ROD is shown to be an underappreciated factor in the level of the serum phosphorus in CKD. The discovery and the elucidation of the mechanism of hyperphosphatemia as a cardiovascular risk in CKD change the view of ROD. Emerging current data suggests a promising role for serum measurements of sclerostin in addition to iPTH in the diagnosis of high bone turnover in chronic kidney disease-5D patients (dialysis patients). Because of the close relationship between ROD and cardiovascular disease, the aim of this study is to investigate the association between sclerostin, arteriovenous fistula thrombosis, echocardiography and carpal tunnel syndrome in maintenance hemodialysis patients.

Conditions

Chronic Kidney Disease; Renal Osteodystrophy; Left Ventricular Hypertrophy

Keywords

sclerostin; arteriovenous fistula thrombosis; carpal tunnel syndrome; echocardiography

Outcome Measures

Primary Outcomes (1)

• Number of Participants with left ventricular hypertrophy or left ventricular dysfunction according to tertiles of the serum sclerostin levels

  3 months

Secondary Outcomes (2)

• Number of Participants with arteriovenous fistula thrombosis

  3 months

• Number of Participants with carpal tunnel syndrome according to tertiles of the serum sclerostin levels

  3 months

Study Arms (1)

Single group

Maintenance hemodialysis patients of minimal 6 months of hemodialysis duration; free of malignancy, infection and autoimmune disease; age over 18 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Maintenance hemodialysis patients (minimum 6 months of duration) No infection, malignancy and autoimmune disease Age\> 18 years

You may qualify if:

• Maintenance hemodialysis patients (minimum 6 months of duration)
• Willingness
• Age \> 18 years

You may not qualify if:

• Infection
• Malignancy
• Autoimmune disease

Sponsors & Collaborators

• RFM Renal Treatment Services: lead

Study Sites (1)

Rfm Renal Tedavi Merkezi

Ankara, Ankara, 06810, Turkey (Türkiye)

Location

Related Publications (4)

• Drueke TB, Lafage-Proust MH. Sclerostin: just one more player in renal bone disease? Clin J Am Soc Nephrol. 2011 Apr;6(4):700-3. doi: 10.2215/CJN.01370211. Epub 2011 Mar 24. No abstract available.

  PMID: 21441122 BACKGROUND

• Cejka D, Herberth J, Branscum AJ, Fardo DW, Monier-Faugere MC, Diarra D, Haas M, Malluche HH. Sclerostin and Dickkopf-1 in renal osteodystrophy. Clin J Am Soc Nephrol. 2011 Apr;6(4):877-82. doi: 10.2215/CJN.06550810. Epub 2010 Dec 16.

  PMID: 21164019 BACKGROUND

• Cejka D, Jager-Lansky A, Kieweg H, Weber M, Bieglmayer C, Haider DG, Diarra D, Patsch JM, Kainberger F, Bohle B, Haas M. Sclerostin serum levels correlate positively with bone mineral density and microarchitecture in haemodialysis patients. Nephrol Dial Transplant. 2012 Jan;27(1):226-30. doi: 10.1093/ndt/gfr270. Epub 2011 May 25.

  PMID: 21613383 BACKGROUND

• Kirkpantur A, Balci M, Turkvatan A, Afsar B. Serum sclerostin levels, arteriovenous fistula calcification and 2-years all-cause mortality in prevalent hemodialysis patients. Nefrologia. 2016;36(1):24-32. doi: 10.1016/j.nefro.2015.07.006. Epub 2015 Nov 3.

  PMID: 26546060 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder; Hypertrophy, Left Ventricular; Sclerosteosis; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• ALPER KIRKPANTUR, MD

  RFM Renal Treatment Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

TU (1)