Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2016
CompletedFirst Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedJanuary 13, 2021
January 1, 2021
2.2 years
June 15, 2017
January 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
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 Outcomes (3)
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
3 months
To evaluate anthropometric data of the patients before and after the intervention.
3 months
Study Arms (2)
Intervention group
ACTIVE COMPARATORGroup that will be receive the diet
control
NO INTERVENTIONGroup that will not receive the diet
Interventions
Nutrition booklet with guidelines on types of fats and glycemic index
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Without hospitalization in the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ticiana da Costa Rodrigues
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ticiana C Rodrigues, Doctor
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2017
First Posted
July 2, 2017
Study Start
December 12, 2016
Primary Completion
February 20, 2019
Study Completion
February 20, 2019
Last Updated
January 13, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share