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

NCT ID: NCT00755456

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

End Stage Renal Disease; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glucose solution

Group Type: ACTIVE_COMPARATOR

PD solution containing glucose

Intervention Type: 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.

Glucose and L-carnitine solution

Group Type: EXPERIMENTAL

PD solution containing glucose and L-carnitine

Intervention Type: 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.

Interventions

PD solution containing glucose

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.

Intervention Type: DRUG

PD solution containing glucose and L-carnitine

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.

Intervention Type: DRUG

Other Intervention Names

Dianeal (Baxter)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iperboreal Pharma Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Bonomini, MD

Role: PRINCIPAL_INVESTIGATOR

G. d'Annunzio University

Arduino Arduini, MD

Role: STUDY_DIRECTOR

Iperboreal Pharma Srl

Locations

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, "Maria SS dello Splendore" Hospital

Giulianova, , Italy

Nephrology and Dialysis Unit, "Renzetti" Hospital

Lanciano, , Italy

Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore

Milan, , Italy

Nephrology and Dialysis Unit, "G. Bernabeo" Hospital

Ortona, , 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

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 23725973 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36472884 (View on PubMed)

Other Identifiers

IP-002-05

Identifier Type: -

Identifier Source: org_study_id