- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03205904
Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
January 12, 2021 updated by: Hospital de Clinicas de Porto Alegre
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC).
Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients.
The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character.
About 10 to 25% of patients develop CF-related diabetes (DRFC), whose pathogenesis is associated with pancreatic fibrosis and destruction.
Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients.
The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase.
Methods: Randomized clinical trial in patients with CF aged over 10 years without hospitalization in the last 4 weeks.
Anthropometric measurements, blood pressure, 24 hour recall and food frequency questionnaire will be evaluated.
Oral glucose tolerance and glycated hemoglobin test will be dosed at baseline and during 12 weeks of follow-up.
The intervention group will receive a nutritional guidance at the beginning of the research.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- Ticiana da Costa Rodrigues
-
-
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
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention group
Group that will be receive the diet
|
Nutrition booklet with guidelines on types of fats and glycemic index
|
No Intervention: control
Group that will not receive the diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
Time Frame: 3 months
|
To evaluate the improvement of glucose levels after the diet intervention.
After 12 weeks of intervention will be performed oral glucose tolerance test
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the levels of HbA1c before and after the intervention
Time Frame: 3 months
|
Evaluate the levels of HbA1c before and after the intervention
|
3 months
|
Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention
Time Frame: 3 months
|
Evaluate the response of FEV 1 (forced expiratory volume) before and after the intervention
|
3 months
|
To evaluate anthropometric data of the patients before and after the intervention.
Time Frame: 3 months
|
Improvement of nutritional status Using weight (kg) and height (cm) and BMI.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ticiana C Rodrigues, Doctor, Hospital de Clínicas de Porto Alegre
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)
December 12, 2016
Primary Completion (Actual)
February 20, 2019
Study Completion (Actual)
February 20, 2019
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
June 28, 2017
First Posted (Actual)
July 2, 2017
Study Record Updates
Last Update Posted (Actual)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 12, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 160206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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-
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