Effect of an L-carnitine-containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

Phase 2

Completed

• Conditions: End Stage Renal Disease; Insulin Resistance
• Interventions: Drug: PD solution containing glucose and L-carnitine; Drug: PD solution containing glucose

• Registration Number: NCT00755456
• Lead Sponsor: Iperboreal Pharma Srl

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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. Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing
4. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
5. Have not experienced peritonitis episodes in the last 3 months
6. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
7. Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
8. Have Kt/V urea measurement > 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit
9. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
10. Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit
11. Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit
12. Be treated by the participating clinical Investigator for a period of at least three months
13. Have understood and signed the Informed Consent Form.

Exclusion Criteria

1. Have a history of drug or alcohol abuse in the six months prior to entering the protocol
2. Be in treatment with androgens
3. Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations)
4. Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
5. Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
6. Have a history of congestive heart failure and clinically significant arrhythmia
7. Have an history of epilepsy or any NCS disease
8. Have malignancy within the past 5 years, including lymphoproliferative disorders
9. Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year
10. Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
11. Have used any investigational drug in the 3 months prior to entering the protocol
12. Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose and L-carnitine solution	PD solution containing glucose and L-carnitine	-
Glucose solution	PD solution containing glucose	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp	time 0, 4 months

Secondary Outcome Measures

Name	Time	Method
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)	-2 weeks, time 0, 2 months, 4 months

Trial Locations

Locations (12)

Renal and Dialysis, Bari Policlinic Hospital; 🇮🇹 Bari, Italy

Renal, Dialysis and Transplant Unit, University of Bari; 🇮🇹 Bari, Italy

Division of Nephrology, University of "G. d'Annunzio"; 🇮🇹 Chieti, Italy

Nephrologyand Dialysis Unit, Desio Hospital; 🇮🇹 Desio, Italy

Nephrology and Dialysis Unit, "G. Bernabeo" Hospital; 🇮🇹 Ortona, Italy

Nephrology and Dialysis Unit, "Renzetti" Hospital; 🇮🇹 Lanciano, Italy

Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore; 🇮🇹 Milano, Italy

Renal Unit, Policlinico MultiMedica; 🇮🇹 Sesto San Giovanni, Italy

Nephrology and Dialysis Unit, "SS Annunziata" Hospital; 🇮🇹 Sulmona, Italy

Division of Nephrology and Dialysis, "Mazzini" Hospital; 🇮🇹 Teramo, Italy

Nephrology and Dialysis Unit, "San Pio da Pietrelcina" Hospital; 🇮🇹 Vasto, Italy

Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital; 🇮🇹 Giulianova, Italy