Clinical trial NCT00755404: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: End Stage Renal Disease
Diabetes
Keywords: Peritoneal dialysis
L-carnitine
Diabetes
Glucose homeostasis
Dyslipidemia
Lead sponsor: Iperboreal Pharma Srl
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement
timeFrame: time 0, 6 months
Secondary outcomes:
measure: To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile
timeFrame: 4 weeks, time 0, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
measure: To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements)
timeFrame: 2 weeks, time 0, 3 months, 6 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Renal, Dialysis and Transplant Unit, University of Bari
city: Chieti
country: Italy
facility: Division of Nephrology, University of "G. d'Annunzio"
city: Desio
country: Italy
facility: Nephrology and Dialysis Unit, Desio Hospital
city: Giulianova
country: Italy
facility: Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital
city: Milano
country: Italy
facility: Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore
city: Ortona
country: Italy
facility: Nephrology and Dialysis Unit, "G. Bernabeo" Hospital
city: Sesto San Giovanni
country: Italy
facility: Renal Unit, Policlinico MultiMedica
city: Teramo
country: Italy
facility: Division of Nephrology and Dialysis, "Mazzini" Hospital
Study officials:
affiliation: University of Bari
name: Francesco P Schena, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iperboreal Pharma Srl
name: Arduino Arduini, MD
role: STUDY_DIRECTOR
References: