We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Iperboreal Pharma Srl.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755456
First Posted: September 19, 2008
Last Update Posted: March 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Iperboreal Pharma Srl
  Purpose
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.

Condition Intervention Phase
End Stage Renal Disease Insulin Resistance Drug: PD solution Drug: PD solution containing L-carnitine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Iperboreal Pharma Srl:

Primary Outcome Measures:
  • To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp [ Time Frame: time 0, 4 months ]

Secondary Outcome Measures:
  • To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile [ Time Frame: -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) [ Time Frame: -2 weeks, time 0, 2 months, 4 months ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: PD solution
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.
Experimental: B Drug: PD solution containing 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755456


Contacts
Contact: Luigi Godi, MD +39 06 79312131 lgodi@harrison-cro.it

Locations
Italy
Renal and Dialysis, Bari Policlinic Hospital Recruiting
Bari, Italy, 70124
Principal Investigator: Pasquale Coratelli, MD         
Renal, Dialysis and Transplant Unit, University of Bari Recruiting
Bari, Italy, 70124
Sub-Investigator: Roberto Corciulo, MD         
Principal Investigator: Francesco P Schena, MD         
Nephology and Dialysis Unit, "Salvini" Hospital Withdrawn
Bollate, Italy, 20021
Division of Nephrology, University of "G. d'Annunzio" Recruiting
Chieti, Italy, 66100
Sub-Investigator: Lorenzo Di Liberato, MD         
Nephrologyand Dialysis Unit, Desio Hospital Not yet recruiting
Desio, Italy, 20100
Principal Investigator: Renzo Scanziani, MD         
Sub-Investigator: Marco Pozzi, MD         
Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital Recruiting
Giulianova, Italy, 64021
Principal Investigator: Giancarlo Marinangeli, MD         
Nephrology and Dialysis Unit, "Renzetti" Hospital Not yet recruiting
Lanciano, Italy, 66034
Principal Investigator: Margherita Maccarone, MD         
Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore Recruiting
Milano, Italy, 20121
Sub-Investigator: Amedeo De Vecchi, MD         
Principal Investigator: Piergiorgio Messa, MD         
Nephrology and Dialysis Unit, "G. Bernabeo" Hospital Recruiting
Ortona, Italy, 66026
Principal Investigator: Antonio Stingone, MD         
Renal Unit, Policlinico MultiMedica Recruiting
Sesto San Giovanni, Italy, 20099
Principal Investigator: Silvio V Bertoli, MD         
Nephrology and Dialysis Unit, "SS Annunziata" Hospital Recruiting
Sulmona, Italy, 67039
Principal Investigator: Paolo Cerasoli, MD         
Division of Nephrology and Dialysis, "Mazzini" Hospital Recruiting
Teramo, Italy, 64100
Principal Investigator: Goffredo Del Rosso, MD         
Nephrology and Dialysis Unit, "San Pio da Pietrelcina" Hospital Recruiting
Vasto, Italy, 66054
Principal Investigator: Bruno Di Paolo, MD         
Sponsors and Collaborators
Iperboreal Pharma Srl
Investigators
Principal Investigator: Mario Bonomini, MD G. d'Annunzio University
Study Director: Arduino Arduini, MD Iperboreal Pharma Srl
  More Information

Responsible Party: Iperboreal Pharma Srl
ClinicalTrials.gov Identifier: NCT00755456     History of Changes
Other Study ID Numbers: IP-002-05
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: March 26, 2013
Last Verified: March 2013

Keywords provided by Iperboreal Pharma Srl:
Peritoneal dialysis
L-carnitine
Insulin resistance
Glucose homeostasis
Dyslipidemia

Additional relevant MeSH terms:
Insulin Resistance
Kidney Failure, Chronic
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs


To Top