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Clinical Trial Details

Trial ID: L1235
Source ID: NCT00755404
Associated Drug: Pd Solution
Title: Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Diabetes
Interventions: DRUG: PD Solution|DRUG: PD solution containing L-carnitine
Outcome Measures: Primary: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement, time 0, 6 months | Secondary: 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
Sponsor/Collaborators: Sponsor: Iperboreal Pharma Srl
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-06
Completion Date: 2013-12
Results First Posted:
Last Update Posted: 2019-06-26
Locations: Renal, Dialysis and Transplant Unit, University of Bari, Bari, 70124, Italy|Division of Nephrology, University of "G. d'Annunzio", Chieti, 66100, Italy|Nephrology and Dialysis Unit, Desio Hospital, Desio, 20100, Italy|Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital, Giulianova, 64021, 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|Division of Nephrology and Dialysis, "Mazzini" Hospital, Teramo, 64100, Italy
URL: https://clinicaltrials.gov/show/NCT00755404