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

March 29, 2021 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38 043
        • CRCM AdulteCHU de Grenoble, Hôpital A. Michallon
      • Grenoble, France, 38043
        • Nephrologie, CHU Grenoble
      • Grenoble, France, 38043
        • Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon
      • Grenoble, France, 38043
        • Service d'Endocrinologie, CHU de Grenoble
      • Grenoble, France, 38043
        • Service de Chirurgie Cardiaque, CHU Grenoble
      • Grenoble, France, 38043
        • Service de Radiologie Interventionnelle, CHU de Grenoble
      • Grenoble, France, 38700
        • Service de Pneumologie, Hôpital A. MICHALLON , CHU de Grenoble
      • Lyon, France, 69 437
        • Service d'Urologie et chirurgie de la Transplantation, Groupement Hospitalier Edouard Herriot
      • Lyon, France, 69437
        • Service de médecine de la transplantation et immunologie clinique, Hôpital Edouard Herriot
      • Lyon, France, 69495
        • CRCM adulte, Centre Hospitalier Lyon-Sud
      • Lyon, France, 69495
        • Service d'Endocrinologie, Pavillon médical
      • Lyon, France, 69495
        • Service d'imagerie radiologique et de médecine nucléaire, Centre Hospitalier Lyon-Sud
      • Lyon, France, 69677
        • Service de Chirurgie Thoracique, HOPITAL LOUIS PRADEL
      • Lyon, France, 69677
        • Service de pneumologie, Hôpital Louis Pradel
      • Nantes, France, 44093
        • Service de pneumologie
      • Nantes, France, 44093
        • Service de la Clinique d'Endocrinologie, maladies métaboliques et Nutrition
      • Nantes, France, 44093
        • Service de Néphrologie et Immuno-transplantation
      • Nantes, France, 44093
        • Service de Radiologie
      • Strasbourg, France, 67 091
        • Service d'endocrinologie, diabète et maladies métaboliques
      • Strasbourg, France, 67091
        • Service d'Anesthésie-Réanimations chirurgicales, Nouvel Hôpital Civil
      • Strasbourg, France, 67091
        • Service d'Anesthésie-Réanimations Chirurgicales
      • Strasbourg, France, 67091
        • Service de chirurgie, Nouvel Hôpital Civil
      • Strasbourg, France, 67091
        • Service de pneumologie, Nouvel Hôpital Civil
      • Strasbourg, France, 67098
        • Service de Radiologie, Hôpital de Hautepierre
      • Suresnes, France, 92150
        • Unité d'Endocrinologie, Diabétologie et Médecine Métabolique - Hôpital Foch
      • Suresnes, France, 92151
        • Service d'Imagerie - Hôpital Foch
      • Suresnes, France, 92151
        • Service de Chirurgie Thoracique et Transplantation Pulmonaire - Hôpital Foch
      • Suresnes, France, 92151
        • Service de Pneumologie - Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patient with cystic fibrosis
  • Patient able to respect the protocol procedures
  • Patient with end-stage respiratory insufficiency indicating a lung transplant
  • Clinical history of cystic fibrosis related diabetes and/or insulin-dependent diabetes, with no residual insulin secretion (C-peptide < 0,5 ng/mL) and/or no response to IV glucagon stimulation: [peak stimulated C-peptide (T6min)/basal plasma C-peptide(T0)] < 2. The absence of insulin secretion will be verified 2 times before inclusion
  • Evolution of diabetes for over 3 years
  • Patient whose glycaemic control obtained with insulin therapy is not satisfactory and could significantly alter quality of life (HbA1c > 7% and/or MAGE index > 1,25). This situation is assessed by a diabetologist.
  • Social Security membership or benefit from Social Welfare
  • Patient who received the results of the medical evaluation required

Non-inclusion criteria:

  • Patient with contra-indication for undergo a lung transplant
  • Patient with an indication of heart, liver or kidney transplantation
  • Patient for which poor therapeutic compliance is expected
  • Patient under oral antidiabetic drug
  • In women of childbearing potential: pregnancy test (urine and / or blood) positive, lactation, or unwilling to use effective contraception for the duration of the study until 3 months after the end . Men: procreation project during the study period up to 3 months after its end, or unwilling to use effective contraception patient.
  • Active infection, including hepatitis B, hepatitis C, HIV
  • Any history of malignancy within the past 5 years, with the exception of cutaneous basal cell carcinomas completely resected. The history of breast or melanoma cancers are an absolute contraindication
  • Alcoholic intoxication or drug addiction
  • Anemia (hemoglobin Hb <10g / dL in women and Hb <11 g / dL in men), lymphopenia (<1000 / uL), neutropenia (<1500 / uL) or thrombocytopenia (<100,000 / uL).
  • Persistent elevated liver enzymes at baseline
  • Portal hypertension identified by oesophageal varice and/or hypersplenism (platelets < 120 000 /mm3) or Child-Pugh score > 6.
  • Use of a medical treatment under investigation within 4 weeks before inclusion
  • All medical situation assessed by an investigator which could interfere with the good management of the project
  • Patient restricted of freedom or unable to give his consent
  • Patient has been included in another study that could interfere with the results of the study
  • Contraindications to the use of experimental drugs (Cellcept®, prednisone, Prograf, prednisolone, methylprednisolone, and pancreatic islets)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient with cystic fibrosis
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metabolic efficiency at 1 year
Time Frame: 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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratio [C-peptide stimulated T6min/ C-peptide basal T0]
Time Frame: 1 year after transplant
Δ C peptide = [ C-peptide stimulated T6min/ C-peptide basal T0] Success if Δ C peptide > 2
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
Every week during the first month, and every month during 1 year
HbA1c
Time Frame: Every 3 months during 1 year after transplant
Every 3 months during 1 year after transplant
C-peptide stimulated by glucagon
Time Frame: Every 3 months during 1 year after transplant
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
Every 3 months during 1 year after transplant
Microalbuminuria & proteinuria
Time Frame: Every 3 months during 1 year after transplant
Every 3 months during 1 year after transplant
Insulin requirements
Time Frame: Every month during 1 year after transplant
Unit/day
Every month during 1 year after transplant
Number of minor hypoglycemia
Time Frame: 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
Every month during 1 year after transplant
Number of major hypoglycemia
Time Frame: Every month during 1 year after transplant
Every month during 1 year after transplant
Glycemic variability (MAGE)
Time Frame: Every 6 months during 1 year after transplant
by continuous glycemic measurement Holter (CGMS) & glycemic reader memory analysis
Every 6 months during 1 year after transplant
duration of hypoglycemia
Time Frame: Every 6 months during 1 year after transplant
by continuous glycemic measurement Holter (CGMS) & glycemic reader memory analysis
Every 6 months during 1 year after transplant
Forced Expiratory Volume (FEV1)
Time Frame: Every month during 1 year after transplant
Every month during 1 year after transplant
Forced Vital Capacity (FVC)
Time Frame: Every month during 1 year after transplant
Every month during 1 year after transplant
Tiffeneau-Pinelli index
Time Frame: Every month during 1 year after transplant
FEV1/FVC
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
Every month during 1 year after transplant
Dyspnea score according to the mMRC scale
Time Frame: Every month during 1 year after transplant
Every month during 1 year after transplant
Oxygen saturation SaO2 room air
Time Frame: Every month during 1 year after transplant
Every month during 1 year after transplant
Median maximum expiration flow
Time Frame: Every month during 1 year after transplant
Every month during 1 year after transplant
Number of episodes of pulmonary rejection
Time Frame: Every visit during 1 year after transplant
requiring a corticosteroid bolus
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
Every visit during 1 year after transplant
Mortality
Time Frame: Every visit during 1 year after transplant
Every visit during 1 year after transplant
Adverse events
Time Frame: Every visit during 1 year after transplant
Every visit during 1 year after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurence KESSLER, MD, PhD, Hopitaux Universitaires de Strasbourg
  • Principal Investigator: Pierre Yves BENHAMOU, MD, phD, University Hospital, Grenoble
  • Principal Investigator: Dominique Grenet, MD, HOPITAL FOCH DE SURESNES
  • Principal Investigator: Charles THIVOLET, MD, Hospices Civils de Lyon
  • Principal Investigator: Thierry BERNEY, MD PhD, CENTRE ROMAND DE TRANSPLANTATION - SUISSE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4790

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Clinical Trials on Combined pancreatic islet and lung transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings