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Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor (GLUCORRECTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512119
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years.

At the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta cell surface and inhibition of CFTR leads to a decrease in insulin secretion.

Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation patients and showed an improvement of the respiratory state in comparison with the placebo group.

These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.


Condition or disease Intervention/treatment
Cystic Fibrosis Homozygous for Phe 508 Del CFTR Glucose Intolerance or Newly Diagnosis Diabetes Drug: Lumacaftor-Ivacaftor treatment

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor
Actual Study Start Date : February 11, 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Ivacaftor

Group/Cohort Intervention/treatment
Patient
Patient with cystic fibrosis homozygous for Phe 508 del CFTR having a glucose intolerance or newly diagnosis diabetes
Drug: Lumacaftor-Ivacaftor treatment
Lumacaftor-Ivacaftor treatment during one year




Primary Outcome Measures :
  1. Measure of 2 hours plasma glucose value (mmol/l) of OGTT, change from baseline at one year of Lumacaftor-Ivacaftor treatment [ Time Frame: Day 0 (traitement beginning) and year 1 ]

Secondary Outcome Measures :
  1. Fasting and one hour glucose value of OGTT (mmol/l) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  2. C peptide and insulin values at T0, 1 , 2 hours of OGTT (µg/l) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  3. Glucose, insulin and C peptide AUC of OGTT (µU/L) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  4. HOMA -R , HOMA-S [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  5. Mean glucose value per day and 2 h after meal (mg/dl) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  6. Duration in hypoglycemic area [hypo CGM = 2 consecutive values below 3.3 mmol/l - % of time spent] [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  7. Duration in hyperglycemic area [for glucose value higher than 7.7 mmol/l, % time /24h] [ Time Frame: Day 0 (traitement beginning) and year 1 ]
    Number hypoglycaemic events (below 3.3mmol/L, from midnight to 6 am) Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl)

  8. Number hypoglycaemic events (below 3.3mmol/L, from midnight to 6 am) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
    Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl)

  9. Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  10. HbA1c (mmol/l and %) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  11. Daily insulin doses (UI/day) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  12. (BMI) body mass index [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  13. Weight (Kg) maximum weight never reached [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  14. Albumin and Pre albumin (g/l) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  15. FEV1, Vital Capacity (VC) (L and %) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  16. O2 saturation (%) [ Time Frame: Day 0 (traitement beginning) and year 1 ]
  17. Number of cures of antibiotics IV and per os /year and interval between 2 cures (week) [ Time Frame: Day 0 (traitement beginning) and year 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with cystic fibrosis homozygous for Phe 508 del CFTR having a glucose intolerance or newly diagnosis diabetes
Criteria

Inclusion Criteria:

  • patients with CF homozygous for the Phe508del CFTR mutation aged 12 years and over
  • Combined Lumacaftor-Ivacaftor treatment scheduled or already started
  • glucose intolerance in OGTT (ADA criteria) or newly diabetes diagnosed at the OGTT (ADA criteria) or diabetic patients with insulin requirement ≤ 0.3 unit / kg / day or without insulin treatment
  • signed informed consent of patient and of one parent OR legal representative for minor subject

Exclusion Criteria:

  • hypersensitivity to the active substances or to any of the excipients of Lumactfor -Ivacaftor
  • lung and/or liver transplant patient
  • Known diabetes with insulin treatment > 0.3 unit / kg / day
  • patient pregnant or wishing to pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512119


Locations
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France
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France, 67000
Centre Hospitalier Universitaire d'Angers
Angers, France, 49033
Hôpital Renée Sabran
Giens, France, 83406
Centre Hospitalier Lyon Sud
Lyon, France, 69000
Hôpital NORD - Assistance Publique Hôpitaux de Marseille
Marseille, France, 13385
Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Hôpital Robert Debré
Paris, France, 75019
American Memorial Hospital
Reims, France, 51092
Clinique "Mucoviscidose" Presqu'île de Perharidy
Roscoff, France, 29684
Hôpital Charles Nicolle
Rouen, France, 76031
Hôpital FOCH
Suresnes, France, 92151
Hôpital Bretonneau - CHRU de Tours
Tours, France, 37044
Hôpital de Clocheville - CHRU de Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03512119    
Other Study ID Numbers: 6403
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
Cystic fibrosis
Glucose tolerance abnormalities
CFTR corrector and potentiator
Additional relevant MeSH terms:
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Cystic Fibrosis
Congenital Abnormalities
Glucose Intolerance
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action