Diabetes, End Stage Renal Disease
Conditions
Keywords
Peritoneal dialysis, L-carnitine, Diabetes, 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 evaluated by measuring insulin requirement.
Interventions
DRUGPD Solution
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 180 days.
DRUGPD solution containing 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 180 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement | time 0, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile | 4 weeks, time 0, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months |
| To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements) | 2 weeks, time 0, 3 months, 6 months |
Countries
Italy
Outcome results
None listed