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

NCT ID: NCT00755404

Last Updated: 2019-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

End Stage Renal Disease; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

PD Solution

Intervention Type: DRUG

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.

B

Group Type: EXPERIMENTAL

PD solution containing L-carnitine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iperboreal Pharma Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco P Schena, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Arduino Arduini, MD

Role: STUDY_DIRECTOR

Iperboreal Pharma Srl

Locations

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

Milan, , 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, , Italy

Countries

Italy

Other Identifiers

IP-003-05

Identifier Type: -

Identifier Source: org_study_id