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Sponsored by: |
Iperboreal Pharma Srl |
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Information provided by: | Iperboreal Pharma Srl |
ClinicalTrials.gov Identifier: | NCT00755404 |
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.
Condition | Intervention | Phase |
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End Stage Renal Disease Diabetes |
Drug: PD Solution Drug: PD solution containing L-carnitine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator |
Drug: PD 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.
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B: Experimental |
Drug: PD 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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luigi Godi, MD | +39 06 79312131 | lgodi@harrison-cro.it |
Italy | |
Nephrology and Dialysis Unit, "G. Bernabeo" Hospital | Recruiting |
Ortona, Italy, 66026 | |
Sub-Investigator: Antonio Stingone, MD | |
Division of Nephrology, University of "G. d'Annunzio" | Recruiting |
Chieti, Italy, 66100 | |
Principal Investigator: Mario Bonomini, MD | |
Division of Nephrology and Dialysis, "Mazzini" Hospital | Recruiting |
Teramo, Italy, 64100 | |
Principal Investigator: Goffredo Del Rosso, MD | |
Renal, Dialysis and Transplant Unit, University of Bari | Active, not recruiting |
Bari, Italy, 70124 | |
Nephology and Dialysis Unit, "Salvini" Hospital | Active, not recruiting |
Bollate, Italy, 20021 | |
Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital | Recruiting |
Giulianova, Italy, 64021 | |
Principal Investigator: Giancarlo Marinangeli, MD | |
Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore | Active, not recruiting |
Milano, Italy, 20121 | |
Renal Unit, Policlinico MultiMedica | Recruiting |
Sesto San Giovanni, Italy, 20099 | |
Principal Investigator: Silvio V Bertoli, MD |
Principal Investigator: | Francesco P Schena, MD | University of Bari |
Study Director: | Arduino Arduini, MD | Iperboreal Pharma Srl |
Responsible Party: | Iperboreal Pharma Srl ( Arduino Arduini ) |
Study ID Numbers: | IP-003-05 |
Study First Received: | September 18, 2008 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00755404 |
Health Authority: | Italy: Ethics Committee |
Peritoneal dialysis L-carnitine Diabetes Glucose homeostasis Dyslipidemia |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Diabetes Mellitus Kidney Failure, Chronic |
Kidney Diseases Insulin Carnitine Dyslipidemias Kidney Failure |
Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |