Clinical trial NCT00755456: Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Official title: Phase 2 Study of the Effect of a Peritoneal Dialysis Solution Containing Glucose (1.5%) and L-carnitine (0.1%) on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Insulin Resistance
Keywords: Peritoneal dialysis
L-carnitine
Insulin resistance
Glucose homeostasis
Dyslipidemia
Lead sponsor: Iperboreal Pharma Srl
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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. 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

Primary outcomes:
measure: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp
timeFrame: time 0, 4 months
Secondary outcomes:
measure: To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile
timeFrame: -2 weeks, time 0, 1 month, 2 months, 3 months, 4 months
measure: To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements)
timeFrame: -2 weeks, time 0, 2 months, 4 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Renal and Dialysis, Bari Policlinic Hospital
city: Bari
country: Italy
facility: Renal, Dialysis and Transplant Unit, University of Bari
city: Chieti
country: Italy
facility: Division of Nephrology, University of "G. d'Annunzio"
city: Desio
country: Italy
facility: Nephrologyand Dialysis Unit, Desio Hospital
city: Giulianova
country: Italy
facility: Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital
city: Lanciano
country: Italy
facility: Nephrology and Dialysis Unit, "Renzetti" Hospital
city: Milano
country: Italy
facility: Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore
city: Ortona
country: Italy
facility: Nephrology and Dialysis Unit, "G. Bernabeo" Hospital
city: Sesto San Giovanni
country: Italy
facility: Renal Unit, Policlinico MultiMedica
city: Sulmona
country: Italy
facility: Nephrology and Dialysis Unit, "SS Annunziata" Hospital
city: Teramo
country: Italy
facility: Division of Nephrology and Dialysis, "Mazzini" Hospital
city: Vasto
country: Italy
facility: Nephrology and Dialysis Unit, "San Pio da Pietrelcina" Hospital
Study officials:
affiliation: G. d'Annunzio University
name: Mario Bonomini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iperboreal Pharma Srl
name: Arduino Arduini, MD
role: STUDY_DIRECTOR
References:
citation: Bonomini M, Di Liberato L, Del Rosso G, Stingone A, Marinangeli G, Consoli A, Bertoli S, De Vecchi A, Bosi E, Russo R, Corciulo R, Gesualdo L, Giorgino F, Cerasoli P, Di Castelnuovo A, Monaco MP, Shockley T, Rossi C, Arduini A. Effect of an L-carnitine-containing peritoneal dialysate on insulin sensitivity in patients treated with CAPD: a 4-month, prospective, multicenter randomized trial. Am J Kidney Dis. 2013 Nov;62(5):929-38. doi: 10.1053/j.ajkd.2013.04.007. Epub 2013 May 29.