A Phase 1/2 interventional study of Combined pancreatic islet and lung transplantation in Cystic Fibrosis, Diabetes Related Cystic Fibrosis and Insulin-dependent Diabetes, sponsored by University Hospital, Strasbourg, France. Completed at 28 sites in France. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by University Hospital, Strasbourg, France · Phase 1/2, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 14 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Non-inclusion criteria:
Patients with end-stage cystic fibrosis
Procedure: Combined pancreatic islet and lung transplantation
Combined pancreatic islet and lung transplant from the same donor for the treatment of patients with end-stage cystic fibrosis
Metabolic efficiency at 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
Time frame: 1 year
Ratio [C-peptide stimulated T6min/ C-peptide basal T0]
Δ C peptide = \[ C-peptide stimulated T6min/ C-peptide basal T0\] Success if Δ C peptide \> 2
Time frame: 1 year after transplant
Ratio [C-peptide/Glucose-Creatinine] & ratio [C-peptide/Glucose]
Time frame: Every week during the first month, and every month during 1 year
HbA1c
Time frame: Every 3 months during 1 year after transplant
C-peptide stimulated by glucagon
Time frame: Every 3 months during 1 year after transplant
Ratio [C-peptide stimulated T6min/ C-peptide basal T0]
Time frame: Every 3 months during 1 year after transplant
Microalbuminuria & proteinuria
Time frame: Every 3 months during 1 year after transplant
Insulin requirements
Unit/day
Time frame: Every month during 1 year after transplant
Number of minor hypoglycemia
defined by a blood glucose level \< 0.6g/L at which the patient is capable of self-sugaring
Time frame: Every month during 1 year after transplant
Number of major hypoglycemia
Time frame: Every month during 1 year after transplant
Glycemic variability (MAGE)
by continuous glycemic measurement Holter (CGMS) \& glycemic reader memory analysis
Time frame: Every 6 months during 1 year after transplant
duration of hypoglycemia
by continuous glycemic measurement Holter (CGMS) \& glycemic reader memory analysis
Time frame: Every 6 months during 1 year after transplant
Forced Expiratory Volume (FEV1)
Time frame: Every month during 1 year after transplant
Forced Vital Capacity (FVC)
Time frame: Every month during 1 year after transplant
Tiffeneau-Pinelli index
FEV1/FVC
Time frame: Every month during 1 year after transplant
Nature of pulmonary infection episodes and nature of acute lung rejection if need be
Time frame: Every month during 1 year after transplant
Dyspnea score according to the mMRC scale
Time frame: Every month during 1 year after transplant
Oxygen saturation SaO2 room air
Time frame: Every month during 1 year after transplant
Median maximum expiration flow
Time frame: Every month during 1 year after transplant
Number of episodes of pulmonary rejection
requiring a corticosteroid bolus
Time frame: Every visit during 1 year after transplant
Number of days of post-transplant hospitalization and during the follow-up
Time frame: Every visit during 1 year after transplant
Mortality
Time frame: Every visit during 1 year after transplant
Adverse events
Time frame: Every visit during 1 year after transplant
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France