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Salusin-alpha - a New Factor in the Pathogenesis of Lipid Abnormalities in Hemodialysis Patients

NCT01448174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2014-10-07

No results posted yet for this study

Summary

Hyperlipidemia and atherosclerosis lead to cardiovascular diseases and are an indirect cause of increased death rate in the general population. This association is still more evident in specific subpopulations, like patients with advanced chronic kidney disease (CKD), especially hemodialysis (HD) patients, due to a higher prevalence of lipid disturbances and atherosclerosis compared to the general population. Cardiovascular events in CKD patients are frequently associated with traditional risk factors, including diabetes, male sex, hypertension, dyslipidemia and advanced age. However, these factors failed to fully account for the increased risk of cardiovascular events in CKD. The efforts are made to identify new risk factors that contribute to the development of atherosclerosis and participate in causes of cardiovascular death. In 2003, there were identified peptides designated salusin-alpha and salusin-beta. Development of atherosclerosis may be suppressed by salusin-alpha. Salusin-alpha may have a lipid lowering effect, similar to that of statins.

The purpose of this study is to investigate whether 1) salusin-alpha is associated with lipid metabolism of HD patients (without or with metabolic syndrome or type 2 diabetes mellitus), similarly or not like in healthy or obese subjects; 2) treatment with atorvastatin and its effects are associated with changes in plasma salusin-alpha concentration, if so - whether it is dependent on the direct influence of atorvastatin on salusin-alpha or associated with a decrease in serum lipid level; 3) salusin-alpha may predict mortality in HD patients.

Conditions

  • Renal Failure Chronic Requiring Hemodialysis
  • Metabolic Syndrome
  • Diabetes Mellitus Type 2
  • Hyperlipidemia

Interventions

DRUG

Atorvastatin

Atorvastatin (10 - 80 mg/day) will be administered orally in the one evening dose in the case of strict indications for such a treatment. Before starting atorvastatin, serum lipid profile will be examined two times, and when both results are abnormal the treatment is started. Duration of administration: * atorvastatin 12 weeks, 6 weeks washout, placebo 12 weeks or * placebo 12 weeks,6 weeks washout,atorvastatin 12 weeks.

Sponsors & Collaborators

  • Poznan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Alicja E. Grzegorzewska, MD, PhD · Chair and Department of Nephrology, Transplantology and Internal Diseases

  • Leszek Niepolski, MD, PhD · BBraun Avitum Dialysis Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01448174 on ClinicalTrials.gov