Status:
WITHDRAWN
Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)
Lead Sponsor:
Iperboreal Pharma Srl
Conditions:
End Stage Renal Disease
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00755404
Start Date
June 1 2007
End Date
December 1 2013
Last Update
June 26 2019
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Renal, Dialysis and Transplant Unit, University of Bari
Bari, Italy, 70124
2
Division of Nephrology, University of "G. d'Annunzio"
Chieti, Italy, 66100
3
Nephrology and Dialysis Unit, Desio Hospital
Desio, Italy, 20100
4
Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital
Giulianova, Italy, 64021