Efficiency of L-Carnitine-containing Peritoneal Dialysis Solutions for diurnal exchanges in diabetes type 2 CAPD patients with ESRD on glucose metabolism. Randomized, parallel study compared versus a Standard Glucose Solution (1.5 or 2.5%)

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Product Name: l‐carnitine + glucose solution 1.5% Product Code: IP015 Pharmaceutical Form: Solution for peritoneal dialysis Current Sponsor code: IP015 Concentration unit: g gram(s) Concentration type: equal Concentration number: 2‐ Product Name: L‐CARNITINE + GLUCOSE SOLUTION 2.5% Product Code: IP025 Pharmaceutical Form: Solution for peritoneal dialysis Current Sponsor code: IP025 Concentration unit: g gram(s) Concentration type: equal Concentration number: 2‐ CONDITION: Patients affected by End Stage Renal Disease (ESRD) treated with Continuous Ambulatory Peritoneal Dialysis (CAPD) ; MedDRA version: 9.1 Level: LLT Classification code 10038444 Term: Renal failure chronic PRIMARY OUTCOME: Main Objective: To assess the efficacy of L‐Carnitine containing PD solution versus a standard glucose solution (1.5 or 2.5%) on insulin sensitivity evaluated by insulin requirement monitoring Primary end point(s): To assess the efficacy of L‐Carnitine containing PD solution versus a standard glucose solution (1.5 or 2.5%) on insulin sensitivity evaluated by insulin requirement monitoring Secondary Objective: 1) To assess the efficacy of L‐Carnitine containing PD solution on triglycerides, cholesterol and lipoprotein profile; ; 2) To assess the efficacy of L‐Carnitine containing PD solution on hematological parameters (hemoglobin); ; 3) To assess the efficacy of L‐Carnitine containg PD solution on concomitant erythropoietin treatment regimen INCLUSION CRITERIA: 1.Age >=18 years 2.Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months 3.Have Type 2 Diabetes, diagnosed according to American Diabetes Association (fasting glucose >=126 mg/dl and 2 h glucose at OGTT >=200 mg/dl), and treated with multiple daily insulin injection or with HbA1c >=8.5% 4.Be in a stable clinical condition during the 4 weeks immediately prior to Run‐In Period as demonstrated by medical history, physical examination and laboratory testing 5.Have a blood hemoglobin concentration > 8,5 g/100ml 6.Have not experienced peritonitis episodes in the last 3 months 7.Be treated with nocturnal exchange bag solution with ecodestrine (Extraneal) for at least 1 month 8.Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal) 9.Have Kt/V urea measurement > 1.
Epistemonikos ID: 2ffd2a3d133209100579caca15d778ce680fa53d
First added on: Aug 21, 2024