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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Iperboreal Pharma Srl
Sponsor:
Information provided by (Responsible Party):
Iperboreal Pharma Srl
ClinicalTrials.gov Identifier:
NCT00755404
First received: September 18, 2008
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 measuring insulin requirement [ Time Frame: time 0, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile [ Time Frame: 4 weeks, time 0, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ] [ Designated as safety issue: No ]
  • To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements) [ Time Frame: 2 weeks, time 0, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2007
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 180 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 180 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755404

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

Locations
Italy
Renal, Dialysis and Transplant Unit, University of Bari Active, not recruiting
Bari, Italy, 70124
Nephology and Dialysis Unit, "Salvini" Hospital Withdrawn
Bollate, Italy, 20021
Division of Nephrology, University of "G. d'Annunzio" Recruiting
Chieti, Italy, 66100
Principal Investigator: Mario Bonomini, MD         
Nephrology and Dialysis Unit, Desio Hospital 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         
Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore Active, not recruiting
Milano, Italy, 20121
Nephrology and Dialysis Unit, "G. Bernabeo" Hospital Recruiting
Ortona, Italy, 66026
Sub-Investigator: Antonio Stingone, MD         
Renal Unit, Policlinico MultiMedica Recruiting
Sesto San Giovanni, Italy, 20099
Principal Investigator: Silvio V Bertoli, MD         
Division of Nephrology and Dialysis, "Mazzini" Hospital Recruiting
Teramo, Italy, 64100
Principal Investigator: Goffredo Del Rosso, MD         
Sponsors and Collaborators
Iperboreal Pharma Srl
Investigators
Principal Investigator: Francesco P Schena, MD University of Bari
Study Director: Arduino Arduini, MD Iperboreal Pharma Srl
  More Information

No publications provided

Responsible Party: Iperboreal Pharma Srl
ClinicalTrials.gov Identifier: NCT00755404     History of Changes
Other Study ID Numbers: IP-003-05
Study First Received: September 18, 2008
Last Updated: March 25, 2013
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Kidney Failure, Chronic
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hyperinsulinism
Carnitine
Dialysis Solutions
Pharmaceutical Solutions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014