Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis
- Conditions
- Cystic FibrosisInsulin-dependent DiabetesDiabetes Related Cystic Fibrosis
- Interventions
- Procedure: Combined pancreatic islet and lung transplantation
- Registration Number
- NCT01548729
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may benefit from combined lung-pancreatic islet transplantation. A recent case series showed that combined bilateral lung and pancreatic islet transplantation is a viable therapeutic option for patients with end-stage CF and CFRD. The use of different organs from a single donor may lead to reduced immunogenicity. As the prevalence of CFRD has increased dramatically with the improved life expectancy of patients with CF, islet transplantation should be considered at the end-stage CF. By restoring metabolic control, the investigators hypothesize that islet transplantation may improve the management of CF patients undergoing lung transplant and decrease the complication rate in the early postoperative period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient with cystic fibrosis Combined pancreatic islet and lung transplantation Patients with end-stage cystic fibrosis
- Primary Outcome Measures
Name Time Method Metabolic efficiency at 1 year 1 year Combined criteria based on the 4 following criteria: weight increase \> 5% compared to inclusion, fasting blood glucose \< 1.1 g/l at 12 months post-transplant (beta score criterion), Reducing insulin requirements (expressed in UI/day) compared to inclusion \& decreased in HbA1c \>= 0.5% (in absolute value) compared to inclusion Success is defined by achieving at least three of these criteria
- Secondary Outcome Measures
Name Time Method HbA1c Every 3 months during 1 year after transplant Ratio [C-peptide stimulated T6min/ C-peptide basal T0] Every 3 months during 1 year after transplant Tiffeneau-Pinelli index Every month during 1 year after transplant FEV1/FVC
Nature of pulmonary infection episodes and nature of acute lung rejection if need be Every month during 1 year after transplant Oxygen saturation SaO2 room air Every month during 1 year after transplant Adverse events Every visit during 1 year after transplant C-peptide stimulated by glucagon Every 3 months during 1 year after transplant Insulin requirements Every month during 1 year after transplant Unit/day
Number of minor hypoglycemia Every month during 1 year after transplant defined by a blood glucose level \< 0.6g/L at which the patient is capable of self-sugaring
Forced Vital Capacity (FVC) Every month during 1 year after transplant Microalbuminuria & proteinuria Every 3 months during 1 year after transplant Median maximum expiration flow Every month during 1 year after transplant Number of days of post-transplant hospitalization and during the follow-up Every visit during 1 year after transplant Forced Expiratory Volume (FEV1) Every month during 1 year after transplant Number of episodes of pulmonary rejection Every visit during 1 year after transplant requiring a corticosteroid bolus
Mortality Every visit during 1 year after transplant Ratio [C-peptide/Glucose-Creatinine] & ratio [C-peptide/Glucose] Every week during the first month, and every month during 1 year Number of major hypoglycemia Every month during 1 year after transplant Glycemic variability (MAGE) Every 6 months during 1 year after transplant by continuous glycemic measurement Holter (CGMS) \& glycemic reader memory analysis
duration of hypoglycemia Every 6 months during 1 year after transplant by continuous glycemic measurement Holter (CGMS) \& glycemic reader memory analysis
Dyspnea score according to the mMRC scale Every month during 1 year after transplant
Trial Locations
- Locations (28)
Service de Radiologie Interventionnelle, CHU de Grenoble
🇫🇷Grenoble, France
Service de Chirurgie Thoracique, HOPITAL LOUIS PRADEL
🇫🇷Lyon, France
Service d'Endocrinologie, Pavillon médical
🇫🇷Lyon, France
Service de Pneumologie - Hôpital Foch
🇫🇷Suresnes, France
Service de Pneumologie
🇫🇷Nantes, France
Service d'Anesthésie-Réanimations chirurgicales, Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Service de Radiologie, Hôpital de Hautepierre
🇫🇷Strasbourg, France
CRCM adulte, Centre Hospitalier Lyon-Sud
🇫🇷Lyon, France
Service de la Clinique d'Endocrinologie, maladies métaboliques et Nutrition
🇫🇷Nantes, France
Service d'Imagerie - Hôpital Foch
🇫🇷Suresnes, France
Service de pneumologie, Hôpital Louis Pradel
🇫🇷Lyon, France
Service d'Anesthésie-Réanimations Chirurgicales
🇫🇷Strasbourg, France
Service de Radiologie
🇫🇷Nantes, France
Service de pneumologie, Nouvel Hôpital Civil
🇫🇷Strasbourg, France
CRCM AdulteCHU de Grenoble, Hôpital A. Michallon
🇫🇷Grenoble, France
Nephrologie, CHU Grenoble
🇫🇷Grenoble, France
Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon
🇫🇷Grenoble, France
Service de Chirurgie Cardiaque, CHU Grenoble
🇫🇷Grenoble, France
Service d'Endocrinologie, CHU de Grenoble
🇫🇷Grenoble, France
Service de Pneumologie, Hôpital A. MICHALLON , CHU de Grenoble
🇫🇷Grenoble, France
Service de médecine de la transplantation et immunologie clinique, Hôpital Edouard Herriot
🇫🇷Lyon, France
Service d'Urologie et chirurgie de la Transplantation, Groupement Hospitalier Edouard Herriot
🇫🇷Lyon, France
Service d'imagerie radiologique et de médecine nucléaire, Centre Hospitalier Lyon-Sud
🇫🇷Lyon, France
Service de Néphrologie et Immuno-transplantation
🇫🇷Nantes, France
Service d'endocrinologie, diabète et maladies métaboliques
🇫🇷Strasbourg, France
Service de chirurgie, Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Unité d'Endocrinologie, Diabétologie et Médecine Métabolique - Hôpital Foch
🇫🇷Suresnes, France
Service de Chirurgie Thoracique et Transplantation Pulmonaire - Hôpital Foch
🇫🇷Suresnes, France