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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucose solution | Active Comparator |
| |
| Glucose and L-carnitine solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD solution containing glucose | Drug | 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 120 days. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp | time 0, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Bonomini, MD | G. d'Annunzio University | Principal Investigator |
| Arduino Arduini, MD | Iperboreal Pharma Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal and Dialysis, Bari Policlinic Hospital | Bari | 70124 | Italy | |||
| Renal, Dialysis and Transplant Unit, University of Bari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23725973 | Result | 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. | |
| 36472884 |
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|
| PD solution containing glucose and L-carnitine | Drug | 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 120 days. |
|
| -2 weeks, time 0, 2 months, 4 months |
| 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 | Milan | 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 |
| Derived |
| Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007333 | Insulin Resistance |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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