Loading clinical trials...

COMPLETEDPHASE2

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

Phase 2 Study of the Effect of a Peritoneal Dialysis Solution Containing Glucose (1.5%) and L-carnitine (0.1%) on Insulin Sensitivity in Patients on Continuous Ambulatory Peritoneal Dialysis

NCT00755456•Iperboreal Pharma Srl

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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
+2 more criteria

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, "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

Key Dates

Start Date

January 1, 2008

Primary Completion Date

September 1, 2012

Completion Date

October 1, 2012

Last Updated

June 26, 2019

Enrollment

ACTUAL participants

Conditions

End Stage Renal DiseaseInsulin Resistance

Interventions

PD solution containing glucose

DRUG

PD solution containing glucose and L-carnitine

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Glucose Profiles in Women With Polycystic Ovary Syndrome

NCT07483723

Polycystic Ovary SyndromeGlucose Profile+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

Glucose Profiles in Women With Polycystic Ovary Syndrome

Effects of Cranberry on Gut and Metabolic Health

EndoForce Post Approval Study

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD