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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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25 January 2021 |
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Main ID: |
NCT03205904 |
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Date of registration:
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15/06/2017 |
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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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Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
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Scientific title:
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Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis. |
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Date of first enrolment:
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December 12, 2016 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03205904 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Ticiana C Rodrigues, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de Clinicas de Porto Alegre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- tolerance glucose test values between 100 and 125mg / dl and or glucose 2h after 75g
of glucose between 140 and 199 mg / dl
- Stable pulmonary disease in the last four weeks
Exclusion Criteria:
- Without hospitalization in the last 3 months
Age minimum:
10 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis-related Diabetes
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Diet
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Primary Outcome(s)
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glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
[Time Frame: 3 months]
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Secondary Outcome(s)
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To evaluate anthropometric data of the patients before and after the intervention.
[Time Frame: 3 months]
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Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention
[Time Frame: 3 months]
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Evaluate the levels of HbA1c before and after the intervention
[Time Frame: 3 months]
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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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