Cystic Fibrosis Clinical Trial
Official title:
Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
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.
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 conditions is observed. A slow release insulin (glargine) has become
available in the market for diabetic patients: its characteristics allow for a single daily
dose, and no need of repeated daily monitoring of glycemia.
In this randomized controlled clinical trial we evaluate whether the anticipated use of
glargine in CF patients with glucose intolerance may prevent the worsening of nutritional
status and pulmonary function.
Eligible patients who will accept to participate to this study will be randomly allocated in
the group who will or will not receive glargine as additional supportive therapy. Patients
will in any case continue the CF therapy prescribed by their treating physicians and their
usual diet. All the patients will be evaluated every three months to assess their
nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th
month after the study entry.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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