Trial · NCT03512119
Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor
NCT03512119, Completed, University Hospital, Strasbourg, France
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor. Trials, record NCT03512119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03512119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor
- NCT number
- NCT03512119
- Status
- Completed
- Enrollment
- 55 participants, actual
- Lead sponsor
- University Hospital, Strasbourg, France
- Conditions
- Cystic Fibrosis Homozygous for Phe 508 Del CFTR, Glucose Intolerance or Newly Diagnosis Diabetes
- Interventions
- Lumacaftor-Ivacaftor treatment
- First posted
- 2018-04-30
- Last updated
- 2021-11-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measure of 2 hours plasma glucose value (mmol/l) of OGTT, change from baseline at one year of Lumacaftor-Ivacaftor treatment | Day 0 (traitement beginning) and year 1 | |
| Secondary | Fasting and one hour glucose value of OGTT (mmol/l) | Day 0 (traitement beginning) and year 1 | |
| Secondary | C peptide and insulin values at T0, 1 , 2 hours of OGTT (µg/l) | Day 0 (traitement beginning) and year 1 | |
| Secondary | Glucose, insulin and C peptide AUC of OGTT (µU/L) | Day 0 (traitement beginning) and year 1 | |
| Secondary | HOMA -R , HOMA-S | Day 0 (traitement beginning) and year 1 | |
| Secondary | Mean glucose value per day and 2 h after meal (mg/dl) | Day 0 (traitement beginning) and year 1 | |
| Secondary | Duration in hypoglycemic area [hypo CGM = 2 consecutive values below 3.3 mmol/l - % of time spent] | Day 0 (traitement beginning) and year 1 | |
| Secondary | Duration in hyperglycemic area [for glucose value higher than 7.7 mmol/l, % time /24h] | 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) |
| Secondary | Number hypoglycaemic events (below 3.3mmol/L, from midnight to 6 am) | Day 0 (traitement beginning) and year 1 | Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl) |
| Secondary | Variability glycemic indexes: MAGE (mg/dl), SD (mg/dl) | Day 0 (traitement beginning) and year 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03512119
GET https://conductscience.org/api/trials/v1/NCT03512119/registered