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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002719-27-IT

Enrollment

Registered

2012-03-13

Start date

2011-12-30

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH CYSTIC FIBROSIS MedDRA version: 14.1 Level: PT Classification code 10011766 Term: Cystic fibrosis pancreatic System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML Pharmaceutical Form: Solution for injection INN or Proposed INN: MECASERMIN CAS Number: 68562-41-4 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): ASSESSMENT OF INDICES OF INSULIN SENSITIVITY SUCH AS HOMEOSTASIS MODEL ASSESSMENT (HOMA)-IR, QUANTITATIVE INSULIN SENSIVITY CHECK (QUICKI), AND THE FASTING GLUCOSE/INSULINE RATIO (FGIR)- ASSESSMENT OF INFLAMMATORY MARKERS- ASSESSMENT OF HOSPITALIZATION RATE FOR INFECTIONS.- SAFETY ENDPOINTS AND ADVERSE EVENTS EVALUATIONS : THE FIRST THREE DAYS OFTREATMENT PATIENTS WILL UNDERGO IGF-I ADMINISTRATION AT THE HOSPITAL WITH GLUCOSE DETECTION 2 TO 4 HOURS AFTER THE INJECTION. THEREFORE PATIENTS WILL RECEIVE A GLUCOMETER TO CONTINUE A REGULAR GLUCOSE MONITORING AT HOME IF NECESSARY. ALL PATIENTS WILL BE TRAINED ON ADEQUATE CARBOHYDRATES INTAKE DURING BREAKFAST.BIOCHEMICAL EVALUATION WILL BE PERFORMED EVERY 3 MONTHS, INCLUDING GLUCOSE DETECTION, AND ABNORMAL LABORATORY FINDINGS WILL BE RECORDED. CHANGES IN FUNDOSCOPIC EXAMINATIONS WILL BE PROMPTLY EVALUATED.BEFORE ENTERING THE PROTOCOL PATIENTS WILL SIGN A INFORMED CONSENT SPECIFYING ANY POSSIBLE ADVERSE EVENT (AE) RELATED TO THE TREATMENT. THEY WILL BE ASKED TO RECORD ANY CLINICAL AE AND TO IMMEDIATELY REFER IT TO THEIR PHYSICIAN WHO’LL BE RESPONSIBLE FOR THE OFFICIAL RECORD OF IT FOLLOWING THE PHARMACOVIGILANCE PROCEDURE. ANY UNDESIRABLE MEDICAL CONDITION OR THE DETERIORATION OF A PRE-EXISTING MEDICAL CONDITION WILL LEAD TO DRUG DISCONTINUATION OR TO A CAREFUL CLINICAL AND BIOCHEMICAL FOLLOW UP ACCORDING TO THE SEVERITY OF THE SINGLE CONDITION.;Timepoint(s) of evaluation of this end point: 24 MONTHS	—

Measure

Time frame

Secondary end point(s): ASSESSMENT OF INDICES OF INSULIN SENSITIVITY SUCH AS HOMEOSTASIS MODEL ASSESSMENT (HOMA)-IR, QUANTITATIVE INSULIN SENSIVITY CHECK (QUICKI), AND THE FASTING GLUCOSE/INSULINE RATIO (FGIR)- ASSESSMENT OF INFLAMMATORY MARKERS- ASSESSMENT OF HOSPITALIZATION RATE FOR INFECTIONS.- SAFETY ENDPOINTS AND ADVERSE EVENTS EVALUATIONS : THE FIRST THREE DAYS OFTREATMENT PATIENTS WILL UNDERGO IGF-I ADMINISTRATION AT THE HOSPITAL WITH GLUCOSE DETECTION 2 TO 4 HOURS AFTER THE INJECTION. THEREFORE PATIENTS WILL RECEIVE A GLUCOMETER TO CONTINUE A REGULAR GLUCOSE MONITORING AT HOME IF NECESSARY. ALL PATIENTS WILL BE TRAINED ON ADEQUATE CARBOHYDRATES INTAKE DURING BREAKFAST.BIOCHEMICAL EVALUATION WILL BE PERFORMED EVERY 3 MONTHS, INCLUDING GLUCOSE DETECTION, AND ABNORMAL LABORATORY FINDINGS WILL BE RECORDED. CHANGES IN FUNDOSCOPIC EXAMINATIONS WILL BE PROMPTLY EVALUATED.BEFORE ENTERING THE PROTOCOL PATIENTS WILL SIGN A INFORMED CONSENT SPECIFYING ANY POSSIBLE ADVERSE EVENT (AE) RELATED TO THE TREATMENT. THEY WILL BE ASKED TO RECORD ANY CLINICAL AE AND TO IMMEDIATELY REFER IT TO THEIR PHYSICIAN WHO’LL BE RESPONSIBLE FOR THE OFFICIAL RECORD OF IT FOLLOWING THE PHARMACOVIGILANCE PROCEDURE. ANY UNDESIRABLE MEDICAL CONDITION OR THE DETERIORATION OF A PRE-EXISTING MEDICAL CONDITION WILL LEAD TO DRUG DISCONTINUATION OR TO A CAREFUL CLINICAL AND BIOCHEMICAL FOLLOW UP ACCORDING TO THE SEVERITY OF THE SINGLE CONDITION.;Timepoint(s) of evaluation of this end point: 24 MONTHS

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Countries

Italy

Contacts

Public ContactSegreteria Scientifica

Comitato Etico Unico per la Provincia di Pram

gideluca@ao.pr.it0521704775

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026