GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS

AZIENDA OSPEDALIERA DI PARMA0 sites20 target enrollmentMarch 13, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 13, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERA DI PARMA

•APPROXIMATELY 20 PATIENTS WILL BE ENROLLED CONSECUTIVELY AT THE REGIONAL CYSTIC FIBROSIS CENTRE IN PARMA (HEAD: DR G. PISI) OVER A 6\-12 MONTH\-PERIOD, BOTH F508DEL HOMOZYGOTE AND HETEROZYGOTE, BOTH WITH NORMAL AND IMPAIRED GLUCOSE TOLERANCE. PATIENTS MUST BE IN STABLE CLINICAL CONDITIONS AT ENROLEMENT.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 11
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 9
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•EXCLUSION CRITERIA WILL BE THE PRESENCE OF ACUTE ILLNESS TREATED BY INTRAVENOUS ANTIBIOTICS WITHIN SIX WEEKS PRIOR TO THE STUDY, A 10% DECREASE IN FEV1 COMPARED TO THE PREVIOUSLY RECORDED VALUE, LIVER DYSFUNCTION AND BURKHOLDERIA CEPACIA INFECTION. STEROID AND AZYTROMYCIN TREATMENTS WILL BE CAREFULLY RECORDED AS WELL AS PSEUDOMONAS AERUGINOSA INFECTION FOR FURTHER ANALYSES. PATIENTS AFFECTED BY ANY DEGREE OF DIABETIC RETINOPATHY WILL BE EXCLUDED AS WELL. DISEASE ACTIVITY AT ENROLEMENT AND DURING TREATMENT WILL BE ASSESSED USING THE SCHWACHMAN\-KULCZYCKI SCORE, WHICH ASSESSES GENERAL DISEASE ACTIVITY, PHYSICAL EXAMINATION, NUTRITION AND X\-RAY FINDINGS (SCHWACHMAN ET AL., 1958\). THE SCORE WILL BE ASSESSED BY A SINGLE PHYSICIAN (GP). SUBJECTS WITH A SCORE BELOW 41 WILL BE CONSIDERED UNSUITABLE FOR THE STUDY AND WILL BE EXCLUDED FOR ETHICAL REASONS.