Status:
COMPLETED
Salusin-alpha - a New Factor in the Pathogenesis of Lipid Abnormalities in Hemodialysis Patients
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
Renal Failure Chronic Requiring Hemodialysis
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 subpo...
Detailed Description
Purpose I, step 1. To investigate whether plasma salusin-alpha is associated with lipid and lipid-related abnormalities in hemodialysis (HD) patients, plasma salusin-alpha concentration, expression of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT01448174
Start Date
October 1 2011
End Date
October 1 2014
Last Update
October 7 2014
Active Locations (1)
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1
BBraun Avitum Dialysis Center
Nowy Tomyśl, Wielkopolska, Poland, 64-300