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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01149005 |
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Date of registration:
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09/06/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cystic Fibrosis (CF) Exacerbation and Insulin Treatment
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Scientific title:
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Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01149005 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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David H Zangen, Dr. |
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Address:
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Telephone:
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97225844111 |
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Email:
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ZangenD@hadassah.org.il |
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Affiliation:
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Name:
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David H Zangen, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hadassah Medical Organization |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed diagnosis of CF according to standard criteria
- Pancreatic insufficiency
- Age > 10 years
- Normal oral glucose tolerance test (OGTT) in the past 12 month.
- Acute pulmonary exacerbation (PE) according to the treating physician requires
treatment with intravenous antibiotics
Exclusion Criteria:
- CF-related diabetes/impaired glucose tolerance test (IGTT) in a mixed meal tolerance
test performed during full remission from pulmonary exacerbation
Age minimum:
10 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Impaired Glucose Tolerance
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Cystic Fibrosis
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Pulmonary Exacerbation
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Intervention(s)
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Drug: Novo Rapid Insulin (Novonordisk)
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Drug: novorapid / humalog short acting insulin
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Primary Outcome(s)
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delta Forced Expiratory Volume in 1 second (FEV1%) predicted
[Time Frame: day 0 of the pulmonary exacerbation, to day 14 of the pulmonary exacerbation]
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Secondary Outcome(s)
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change in Body Mass Index (BMI)
[Time Frame: baseline BMI will be compared with BMI on day 0- the day of hospitalization due to the pulmonary exacerbation, and to day 14, after 2 weeks of Intra Venous (IV)Antibiotic therapy, due to Pulmonary Exacerbation (PE).]
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Secondary ID(s)
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CF-Insulin-HMO-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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