CFDB - Cystic Fibrosis DataBase

primary studies published RCT

One-year glargine treatment can improve the course of lung disease in children and adolescents with cystic fibrosis and early glucose derangements.

Study design (if review, criteria of inclusion for studies)

open clinical trial

Participants

CF population was screened for glucose tolerance. CF patients with age >10 yr were screened with fasting hyperglycemia (FH). CF patients with age >10 yr without FH and those with age <10 yr with occasional FH were evaluated for glucose abnormalities on the basis of oral glucose tolerance test and/or continuous glucose monitoring system.

Interventions

All CF patients with glucose derangements were enrolled in an open clinical trial with glargine.

Outcome measures

Body mass index (BMI) z-score, forced expiratory volume in the first second (FEV(1)), number of acute pulmonary exacerbations and hemoglobin A1c, were as outcome measures at baseline and after 1 yr of treatment.

Main results

After 12 months of therapy, BMI z-score improved only in patients with baseline BMI z-score less than -1 (p = 0.017). An 8.8% increase in FEV(1) (p = 0.01) and 42% decrease in the number of pulmonary exacerbations (p = 0.003) were found in the whole group compared with previous 12 months of therapy.

Authors' conclusions

Glargine could represent an innovative strategy to prevent lung disease progression in CF patients with early glucose derangements. Larger controlled trials are needed to better clarify the effects of insulin on clinical status in CF patients with early glucose derangements.

Keywords: Glargine; Insulin; Hypoglycemic Agents; pharmacological_intervention; Glucose Intolerance; Pancreatic Diseases; Gastrointestinal Diseases; Respiratory Tract Diseases;