Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Primary Purpose
End Stage Renal Disease, Diabetes
Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
PD Solution
PD solution containing L-carnitine
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Peritoneal dialysis, L-carnitine, Diabetes, Glucose homeostasis, Dyslipidemia
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
- 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)
- 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
- Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
- Have not experienced peritonitis episodes in the last 3 months
- Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
- Be treated with 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
- Have Kt/V urea measurement > 1.7 per week in a previous test performed within 3 months that should be confirmed at Baseline Visit
- Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
- 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
- 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
- Be treated by the participating clinical Investigator for a period of at least three months
- Have understood and signed the Informed Consent Form.
Exclusion Criteria:
- Have a history of drug or alcohol abuse in the six months prior to entering the protocol
- Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C < 8.5%
- Be in treatment with androgens
- Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
- Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
- Have a history of congestive heart failure and clinically significant arrhythmia
- Have an history of epilepsy or any CNS disease
- Have malignancy within the past 5 years, including lymphoproliferative disorders
- Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
- Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
- Have used any investigational drug in the 3 months prior to entering the protocol
- Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
Sites / Locations
- Renal, Dialysis and Transplant Unit, University of Bari
- Division of Nephrology, University of "G. d'Annunzio"
- Nephrology and Dialysis Unit, Desio Hospital
- Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital
- Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore
- Nephrology and Dialysis Unit, "G. Bernabeo" Hospital
- Renal Unit, Policlinico MultiMedica
- Division of Nephrology and Dialysis, "Mazzini" Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement
Secondary Outcome Measures
To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile
To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements)
Full Information
NCT ID
NCT00755404
First Posted
September 18, 2008
Last Updated
June 24, 2019
Sponsor
Iperboreal Pharma Srl
1. Study Identification
Unique Protocol Identification Number
NCT00755404
Brief Title
Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iperboreal Pharma Srl
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Diabetes
Keywords
Peritoneal dialysis, L-carnitine, Diabetes, Glucose homeostasis, Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PD Solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PD solution containing L-carnitine
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement
Time Frame
time 0, 6 months
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months
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)
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
Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)
Have not experienced peritonitis episodes in the last 3 months
Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
Be treated with 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)
Have Kt/V urea measurement > 1.7 per week in a previous test performed within 3 months that should be confirmed at Baseline Visit
Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit
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
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
Be treated by the participating clinical Investigator for a period of at least three months
Have understood and signed the Informed Consent Form.
Exclusion Criteria:
Have a history of drug or alcohol abuse in the six months prior to entering the protocol
Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C < 8.5%
Be in treatment with androgens
Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)
Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)
Have a history of congestive heart failure and clinically significant arrhythmia
Have an history of epilepsy or any CNS disease
Have malignancy within the past 5 years, including lymphoproliferative disorders
Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
Have a history of L-Carnitine therapy or use in the month prior to entering the protocol
Have used any investigational drug in the 3 months prior to entering the protocol
Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco P Schena, MD
Organizational Affiliation
University of Bari
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arduino Arduini, MD
Organizational Affiliation
Iperboreal Pharma Srl
Official's Role
Study Director
Facility Information:
Facility Name
Renal, Dialysis and Transplant Unit, University of Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Division of Nephrology, University of "G. d'Annunzio"
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Nephrology and Dialysis Unit, Desio Hospital
City
Desio
ZIP/Postal Code
20100
Country
Italy
Facility Name
Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital
City
Giulianova
ZIP/Postal Code
64021
Country
Italy
Facility Name
Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Nephrology and Dialysis Unit, "G. Bernabeo" Hospital
City
Ortona
ZIP/Postal Code
66026
Country
Italy
Facility Name
Renal Unit, Policlinico MultiMedica
City
Sesto San Giovanni
ZIP/Postal Code
20099
Country
Italy
Facility Name
Division of Nephrology and Dialysis, "Mazzini" Hospital
City
Teramo
ZIP/Postal Code
64100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
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