EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUS

Conditions: PATIENTS WITH CYSTIC FIBROSIS
MedDRA version: 14.1Level: PTClassification code 10011766Term: Cystic fibrosis pancreaticSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-002719-27-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI PARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate changes in AUCG, AUCI, insulinogenic index, WBISI calculated from an OGTT during the period of treatment, and to assess changes in FPIR and AIR calculated from an IVGTT.;Secondary Objective: 1. To evaluate changes in ESR, hs-CRP, and IL-6 serum concentrations in response to IGF-I treatment.2. To evaluate the changes in IGF-I, IGFBP-1, IGFBP-2 in response to IGF-I treatment.serum concentrations.;Primary end point(s): TO EVALUATE CHANGES IN AREA UNDER THE CURVE FOR BLOOD GLUCOSE CONCENTRATION (AUCG), AREA UNDER THE CURVE FOR INSULIN (AUCI), INSULINOGENIC INDEX(IGI), WHOLE BODY INSULIN SENSITIVITY INDEX (WBISI) CALCULATED FROM AN OGTT DURING THE PERIOD OF TREATMENT;Timepoint(s) of evaluation of this end point: 24 MONTHS

Secondary Outcome Measures