Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD Solution | 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 180 days. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement | time 0, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco P Schena, MD | University of Bari | Principal Investigator |
| Arduino Arduini, MD | Iperboreal Pharma Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renal, Dialysis and Transplant Unit, University of Bari | Bari | 70124 | Italy | |||
| Division of Nephrology, University of "G. d'Annunzio" |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PD solution containing 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 180 days. |
|
| 2 weeks, time 0, 3 months, 6 months |
| 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 | Milan | 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 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003920 | Diabetes Mellitus |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided