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Clinical Trial Details

Trial ID: L1354
Source ID: NCT00755456
Associated Drug: Pd Solution Containing Glucose
Title: Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Insulin Resistance
Interventions: DRUG: PD solution containing glucose|DRUG: PD solution containing glucose and L-carnitine
Outcome Measures: Primary: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp, time 0, 4 months | Secondary: 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
Sponsor/Collaborators: Sponsor: Iperboreal Pharma Srl
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 35
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-01
Completion Date: 2012-10
Results First Posted:
Last Update Posted: 2019-06-26
Locations: Renal and Dialysis, Bari Policlinic Hospital, Bari, 70124, Italy|Renal, Dialysis and Transplant Unit, University of Bari, Bari, 70124, Italy|Division of Nephrology, University of "G. d'Annunzio", Chieti, 66100, Italy|Nephrologyand Dialysis Unit, Desio Hospital, Desio, 20100, Italy|Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital, Giulianova, 64021, Italy|Nephrology and Dialysis Unit, "Renzetti" Hospital, Lanciano, 66034, Italy|Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore, Milano, 20121, Italy|Nephrology and Dialysis Unit, "G. Bernabeo" Hospital, Ortona, 66026, Italy|Renal Unit, Policlinico MultiMedica, Sesto San Giovanni, 20099, Italy|Nephrology and Dialysis Unit, "SS Annunziata" Hospital, Sulmona, 67039, Italy|Division of Nephrology and Dialysis, "Mazzini" Hospital, Teramo, 64100, Italy|Nephrology and Dialysis Unit, "San Pio da Pietrelcina" Hospital, Vasto, 66054, Italy
URL: https://clinicaltrials.gov/show/NCT00755456