Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis; Insulin-dependent Diabetes; Diabetes Related Cystic Fibrosis

• 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

Study Timeline

• Study First Submitted: 2012-02-10
• Study Start: 2012-02-25
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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
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
HbA1c	Every 3 months during 1 year after transplant
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)

CRCM AdulteCHU de Grenoble, Hôpital A. Michallon; 🇫🇷 Grenoble, France

Nephrologie, CHU Grenoble; 🇫🇷 Grenoble, France

Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon; 🇫🇷 Grenoble, France

Service d'Endocrinologie, CHU de Grenoble; 🇫🇷 Grenoble, France

Service de Chirurgie Cardiaque, CHU Grenoble; 🇫🇷 Grenoble, France

Service de Radiologie Interventionnelle, CHU de Grenoble; 🇫🇷 Grenoble, France

Service de Pneumologie, Hôpital A. MICHALLON , CHU de Grenoble; 🇫🇷 Grenoble, France

Service d'Urologie et chirurgie de la Transplantation, Groupement Hospitalier Edouard Herriot; 🇫🇷 Lyon, France

Service de médecine de la transplantation et immunologie clinique, Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CRCM adulte, Centre Hospitalier Lyon-Sud; 🇫🇷 Lyon, France

Scroll for more (18 remaining)