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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Poznan University of Medical Sciences
• Treatments: Atorvastatin; Atorvastatin Calcium

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