Efficacy of slow-release insulin (glargine) in patients with cystic fibrosis and glucose intolerance with worsening clinical parameters.
| DEC-NET Serial number IT499 | |
| Published online | 07/10/2005 10.26.00 |
| Last updated | 10/11/2005 10.42.37 |
| Other protocol ID number | |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | Cystic fibrosis |
| Experimental drug | |
| Insulina Glargine | |
| Gender | Both |
| Age (range) | > 10 years or older |
Eligibility criteria | |
| Inclusion criteria | |
| - Cystic Fibrosis - Glucose intolerance: 2 pathologic oral glucose load curves within a 2-3 month period - At least one of the following: . BMI less than 10^th percentile for age and sex . In the last year, less of one percentile class for age and sex . FEV1 less than or egual to 80% of the abovementioned . FEV1 decrease greater than or egual to 10% in the last year. | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy Safety |
| Design | Controlled Randomised |
| Purpose of study | |
| To improve the nutritional status of patients with Cystic Fibrosis with glucose intolerance and to improve glucose metabolic compensation and respiratory function. | |
| Principal investigator | |
| Name | Prof. Renata Lorini . Dr. Laura Minicucci |
| Institution | Istituto Giannina Gaslini |
| Postal address | Largo G. Gaslini, 5 |
| City | Genova |
| Country | ITALY |
| Phone | 010 5636654 |
| Fax | |
| renatalorini@ospedale-gaslini.ge.it . lauraminicucci@ospedale-gaslini.ge.it | |
| Promoter |
| IRCSS - Istituto Giannina Gaslini (Scientific organisation) |
| Participating centres |
| Centro Fibrosi Cistica di Genova (Genova) |
| Centro Fibrosi Cistica di Bari (Bari) |
| Centro Fibrosi Cistica di Cerignola (Cerignola (Foggia)) |
| Centro Fibrosi Cistica di Firenze (Firenze) |
| Centro Fibrosi Cistica di Messina (Messina) |
| Centro Fibrosi Cistica di Milano (Milano) |
| Centro Fibrosi Cistica di Napoli (Napoli) |
| Centro Fibrosi Cistica di Palermo (Palermo) |
| Centro Fibrosi Cistica di Parma (Parma) |
| Centro Fibrosi Cistica - Bambin Gesł (Roma) |
| Centro Fibrosi Cistica . La Sapienza (Roma) |
| Centro Fibrosi Cistica di Trieste (Trieste) |
| ISRCTN | EudraCT |
