A new clinical trial for Cystic Fibrosis is now recruiting participants aged between 18 to 60 years old with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD). The study is entitled “Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis (PIM)” and is an interventional study testing the efficacy of performing combined pancreatic islet and lung transplantation as new techniques for improving CF patients’ health outcomes.
The rationale behind the trial is that by restoring pancreatic metabolic control in CF patients undergoing lung transplants, patients will experience improved outcomes by reducing the prevalence of severe CF-related diabetes (CFRD). Additionally, the trial will also underscore the advantages in preventing immune rejection by performing a pancreatic islet and lung transplant from the same donor. This will be addressed in patients with end-stage cystic fibrosis (CF).
Specifically, the trial seeks to evaluate glucagon-stimulated plasma C-peptide concentrations, an estimate of patients’ endogenous insulin secretion, as its primary endpoint. Additionally, the study will also determine a series of secondary outcomes related to pancreatic metabolism, including patients’ insulin needs and hypoglycemic episodes, as well as lung performance, such as Forced Vital Capacity (FVC), Maximal Expired Volume per second (VEMS) and lung infection events.
The trial, which is being led by the University Hospital, Strasbourg, France, began in March 2012 and the estimated date of primary outcome data completion is March 2017. The researchers hope that by studying this new approach, they can develop new strategies for improving the onset of CFRD and address both lung and pancreatic issues together.
Patients are encouraged to participate but are advised to consult with their doctor and family. The application, as well as further information, should include the ClinicalTrials.gov identifier NCT01548729 and can be found here.