Status:
UNKNOWN
Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
Lead Sponsor:
Fondazione per la ricerca sulla Fibrosi Cistica
Conditions:
Cystic Fibrosis
Glucose Intolerance
Eligibility:
All Genders
10-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.
Detailed Description
Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general condi...
Eligibility Criteria
Inclusion
- Ascertained diagnosis of CF
- Age ≥ 10 years
- Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: \>140 mg% and \<200 mg%) at 2-6 months' interval between each other
- At least one of the following conditions:
- BMI (body mass index) \< 10th centile for age and sex (according to Rolland Cachera 1991)
- Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991)
- FEV1 ≤ 80% of predicted
- FEV1 decrease ≥ 10% in the last year
Exclusion
- Specific contraindications for the use of glargine
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00687466
Start Date
August 1 2005
End Date
October 1 2009
Last Update
August 4 2009
Active Locations (6)
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1
Pediatric Department, General Hospital,CF Center
Cerignola (Foggia), Italy
2
Ospedale Maggiore Policlinico, Adult CF Center
Milan, Italy
3
Pediatric Department, Federico II University, Pediatric CF Center
Napoli, Italy
4
Pediatric Department G.De Cristina Hospital CF Center
Palermo, Italy