effect of an l-carnitine-containing peritoneal dialysis (pd) solution on insulin sensitivity in diabetic patients on continuous ambulatory peritoneal dialysis (capd)

Conditions: End Stage Renal Disease; Diabetes

Summary: the current study is initiated in order to assess the impact of a pd solution containing l-carnitine on insulin sensitivity evaluated by measuring insulin requirement.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. have a diagnosis of esrd and have been on continuous ambulatory peritoneal dialysis (capd) for at least 3 months 3. have type 2 diabetes, diagnosed according to american diabetes association (fasting glucose ≥126 mg/dl and 2 h glucose at ogtt ≥200 mg/dl), and treated with multiple daily insulin injection or with hba1c \> 8.5% (no oral antidiabetic) 4. be in a stable clinical condition during the four weeks immediately prior to screening period as demonstrated by medical history, physical examination and laboratory testing 5. have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with investigators) 6. have not experienced peritonitis episodes in the last 3 months 7. be treated with extraneal (nocturnal exchange bag solution) for at least 1 month 8. be treated with 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (extraneal) 9. have kt/v urea measurement \> 1.7 per week in a previous test performed within 3 months that should be confirmed at baseline visit 10. have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at baseline visit 11. have a d/p creatinine ratio at peritoneal equilibration test (pet) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at baseline visit 12. have a d/p glucose ratio at peritoneal equilibration test (pet) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at baseline visit 13. be treated by the participating clinical investigator for a period of at least three months 14. have understood and signed the informed consent form. exclusion criteria: 1. have a history of drug or alcohol abuse in the six months prior to entering the protocol 2. type 2 diabetic patients under oral antidiabetic treatment with hba1c \< 8.5% 3. be in treatment with androgens 4. have clinically significant abnormal liver function test (sgot, sgpt, and gamma-gt \> 2 times the upper normal limit) 5. have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc) 6. have a history of congestive heart failure and clinically significant arrhythmia 7. have an history of epilepsy or any cns disease 8. have malignancy within the past 5 years, including lymphoproliferative disorders 9. have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug 10. have a history of l-carnitine therapy or use in the month prior to entering the protocol 11. have used any investigational drug in the 3 months prior to entering the protocol 12. be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means

Keywords: peritoneal dialysis l-carnitine diabetes glucose homeostasis dyslipidemia