Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis-related Diabetes
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To evaluate anthropometric data of the patients 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)
- Evaluate the levels of HbA1c before and after the intervention(3 months)