Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

Phase 2

Withdrawn

• Conditions: End Stage Renal Disease; Diabetes
• Interventions: Drug: PD Solution; Drug: PD solution containing L-carnitine

• Registration Number: NCT00755404
• 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 evaluated by measuring insulin requirement.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-09-18
• Study First Submitted QC: 2008-09-18
• Study First Posted: 2008-09-19
• Status Verified: 2013-03
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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% (No oral antidiabetic)
4. 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
5. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
6. Have not experienced peritonitis episodes in the last 3 months
7. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
8. Be treated with 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 > 1.7 per week in a previous test performed within 3 months that should be confirmed at Baseline Visit
10. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
11. 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
12. 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
13. Be treated by the participating clinical Investigator for a period of at least three months
14. 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. Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C < 8.5%
3. Be in treatment with androgens
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 CNS 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
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
A	PD Solution	-
B	PD solution containing L-carnitine	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement	time 0, 6 months

Secondary Outcome Measures

Name	Time	Method
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)	2 weeks, time 0, 3 months, 6 months

Trial Locations

Locations (8)

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

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

Nephrology and Dialysis Unit, Desio Hospital; 🇮🇹 Desio, Italy

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

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

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

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

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