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

This study is currently recruiting participants.
Verified October 2012 by Poznan University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Alicja E. Grzegorzewska, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01448174
First received: October 5, 2011
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Failure Chronic Requiring Hemodialysis
Metabolic Syndrome
Diabetes Mellitus Type 2
Hyperlipidemia
 Drug: Atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Salusin-alpha - a New Factor in the Pathogenesis of Lipid Abnormalities in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:
  • normalization of serum LDL cholesterol [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 310
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: atorvastatin

The prospective, randomized, double-blind, placebo-controlled study:

  • will be preceded by one month non-pharmacological treatment of hyperlipidemia (prerandomization phase)
  • 130 hyperlipidemic hemodialysis (HD) patients will be randomly assigned to receive blinded study drug: 65 patients will be allocated to start with atorvastatin and 65 patients - with placebo.

Atorvastatin will be administered and monitored according to the K/DOQI guidelines (2003).

The prospective, observational study:

- 35 hyperlipidemic patients will be followed for 30 weeks on the prescribed non-pharmacological treatment of hyperlipidemia

 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.
Other Name: ATC: C 10 AA 05
No Intervention: Lifestyle counseling

Protocol of the prospective study in obese persons:

  • after taking the anthropometric measurements and collecting a blood sample, the start of weight lowering therapy with a prescribed diet and planned physical activity
  • follow-up for 30 weeks (measurement of body weight every week).
No Intervention: The controls (healthy volunteers)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For HD patients:

  • HD vintage at least 3 months
  • signed consent for participation in the study

For obese persons:

  • BMI > 30 kg/m2
  • eGFR > 60 ml/min/1.73 m2 BSA
  • interest in weight loss according to weight loss diet protocol (WLDP)
  • signed consent for participation in the study

For controls (healthy volunteers):

  • declared health, comfort
  • no substantial changes in the medical interview and physical examination
  • no medication
  • signed consent for participation in the study

Exclusion Criteria:

For HD patients:

  • active thyroid gland disease and/or thyreotropic medication
  • treatment with corticosteroids, immunosuppressants or hormones
  • treatment with statins or fibrates in 6 weeks before the study commencement
  • diagnosis of genetic lipid abnormalities
  • neoplastic disease
  • acute coronary syndrome and/or cerebral stroke in 6 months before the study commencement
  • surgery in 3 months before the study commencement
  • plasma activities of ALT and/or AST exceeding 3 times the upper laboratory normal limit
  • non compensated diabetes mellitus

For obese persons:

  • a known history of moderate or severe cardiovascular disease, stroke or transient ischemic attack
  • uncontrolled hypertension
  • severe dyslipidemia (triglycerides > 500 mg/dl, total cholesterol > 350 mg/dl) or taking lipid-lowering agents at the recruitment or 6 weeks before
  • serious chronic disease requiring active treatment (example with glucocorticoids, antineoplastic agents, psychoactive agents, bronchodilators on a regular basis, insulin or oral hypoglycemic drugs)
  • women of child-bearing potential using an effective form of hormonal birth control, pregnant or lactating women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448174

Contacts
Contact: Alicja E. Grzegorzewska, MD, PhD 696 0844 87 ext 48 alicja_grzegorzewska@yahoo.com
Contact: Leszek Niepolski, MD, PhD 602756126 ext 48 leszek.niepolski@avitum.com.pl

Locations
Poland
BBraun Avitum Dialysis Center Recruiting
Nowy Tomyśl, Wielkopolska, Poland, 64-300
Contact: Leszek Niepolski, MD, PhD     602756126 ext 48     leszek.niepolski@avitum.com.pl    
Principal Investigator: Leszek Niepolski, MD, PhD            
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Study Chair: Alicja E. Grzegorzewska, MD, PhD Chair and Department of Nephrology, Transplantology and Internal Diseases
Principal Investigator: Leszek Niepolski, MD, PhD BBraun Avitum Dialysis Center
  More Information

Publications:

Responsible Party: Alicja E. Grzegorzewska, Full Professor, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01448174     History of Changes
Other Study ID Numbers: ALGN-001
Study First Received: October 5, 2011
Last Updated: October 1, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Poznan University of Medical Sciences:
salusin-alpha
atorvastatin
CD36
Hemodialysis

Additional relevant MeSH terms:
Congenital Abnormalities
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Kidney Failure, Chronic
Renal Insufficiency
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Renal Insufficiency, Chronic
Kidney Diseases
 Urologic Diseases
Insulin Resistance
Hyperinsulinism
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013