End Stage Renal Disease, Insulin Resistance
Conditions
Keywords
Peritoneal dialysis, L-carnitine, Insulin resistance, Glucose homeostasis, Dyslipidemia
Brief summary
The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity measured by a hyperinsulinemic euglycemic clamp.
Interventions
DRUGPD solution containing glucose
Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchange. PD solutions are instilled for 120 days.
DRUGPD solution containing glucose and L-carnitine
Instillation of PD solutions containing Glucose (1.5 or 2.5%, w/v) and L-carnitine (0.1%, w/v) for the diurnal exchanges, and 1 PD solution containing icodextrin (7.5 w/v) for nocturnal exchanges. PD solutions are instilled for 120 days.
Sponsors
Iperboreal Pharma Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 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 4. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators) 5. Have not experienced peritonitis episodes in the last 3 months 6. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month 7. Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal) 8. Have Kt/V urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit 9. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit 10. 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 11. 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 12. Be treated by the participating clinical Investigator for a period of at least three months 13. 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. Be in treatment with androgens 3. Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations) 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 NCS 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, particularly if patient's life expectancy is less than 1 year 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp | time 0, 4 months |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile | -2 weeks, time 0, 1 month, 2 months, 3 months, 4 months |
| To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements) | -2 weeks, time 0, 2 months, 4 months |
Countries
Italy
Outcome results
None listed