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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00755404
• Other study ID #: IP-003-05
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Iperboreal Pharma Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• End Stage Renal Disease
• Insulin Resistance
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Renal, Dialysis and Transplant Unit, University of Bari	Bari
Italy	Division of Nephrology, University of "G. d'Annunzio"	Chieti
Italy	Nephrology and Dialysis Unit, Desio Hospital	Desio
Italy	Nephrology and Dialysis Unit, "Maria SS dello Splendore" Hospital	Giulianova
Italy	Division of Nephrology and Dialysis, Ospedale Policlinico Maggiore	Milano
Italy	Nephrology and Dialysis Unit, "G. Bernabeo" Hospital	Ortona
Italy	Renal Unit, Policlinico MultiMedica	Sesto San Giovanni
Italy	Division of Nephrology and Dialysis, "Mazzini" Hospital	Teramo

Sponsors (1)

Lead Sponsor	Collaborator
Iperboreal Pharma Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of L-Carnitine containing PD solution on insulin sensitivity evaluated by measuring insulin requirement		time 0, 6 months
Secondary	To assess the efficacy of L-Carnitine containing PD solution on plasma lipids and lipoprotein profile		4 weeks, time 0, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Secondary	To assess the efficacy of L-Carnitine containing PD solution on hematological parameters (hemoglobin and EPO requirements)		2 weeks, time 0, 3 months, 6 months