Cystic Fibrosis Clinical Trial
Official title:
Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
The purpose of the study is to evaluate whether insulin treatment during pulmonary exacerbation (PE) in patients with Cystic Fibrosis (CF)and normoglycemia improves their short term outcome by normalizing the glycemic profile and enhancing recovery. the investigators would like to evaluate whether insulin treatment during exacerbation improves both the general clinical condition of these patients and also has a protecting effect on ß-cells by preventing the deleterious effect of "chronic" hyperglycemia.
The life expectancy of patients with cystic fibrosis (CF) has increased over the last
decades due to improved understanding of the disease and new treatments. CF patients who
live longer develop glucose intolerance and cystic fibrosis related diabetes (CFRD), in
fact, routine annual screening by Oral Glucose Tolerance Tests (OGTT) shows that the
prevalence of CFRD increases with age. CFRD is primarily an insulinopenic condition
characterized by an impaired and delayed insulin secretion, as a consequence of fibrosis in
the exocrine pancreatic tissue that compromises the ß-cell function.
The occurrence of CFRD is significantly related to increased morbidity and mortality. Based
on data from the CF Patients Registry in the USA, the mortality rate of patients with CFRD
is six-fold higher than that of patients without CFRD.
Our pilot study proved that during pulmonary exacerbation (PE), CF patients with Normal
Glucose Tolerance (NGT) exhibited early latent diabetic glucose intolerance in Oral Glucose
Tolerance Test(OGTT) which becomes completely normalized 3-4 weeks after resolution of PE.
These patients who are considered to be normoglycemic may experience relatively long periods
of hyperglycemia during recurrent events of pulmonary infections. Chronically increased
glucose values during PE have an adverse impact on pulmonary function both during PE and in
the long-term. Hyperglycemia may increase the duration and extent of recovery from PE.
Furthermore it may impair the ability to overcome lung infections by directly stimulating
the growth of respiratory pathogens. Finally, hyperglycemia per-se during stressful
conditions may worsen the general outcome.
Insulin therapy is considered routine treatment for patients with CFRD. In addition to
normalizing glucose levels, insulin has a beneficial effect on general pulmonary function
and nutritional status, possibly due to its anabolic effect. No routine or formal guidelines
for treating PE hyperglycemia are currently available. Normal Glucose Tolerance
(NGT)patients, who are hyperglycemic during PE only, are generally not intensively treated
for this condition, except if the treating physician decides on interventional insulin
treatment. Some patients may experience relatively long periods of hyperglycemia during
recurrent events of pulmonary infections.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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