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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Group that will be receive the diet |
|
| control | No Intervention | Group that will not receive the diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Dietary Supplement | Nutrition booklet with guidelines on types of fats and glycemic index |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the levels of HbA1c before and after the intervention | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ticiana C Rodrigues, Doctor | Hospital de Clinicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ticiana da Costa Rodrigues | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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. | Improvement of nutritional status Using weight (kg) and height (cm) and BMI. | 3 months |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |