Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Cystic Fibrosis-related Diabetes
• Interventions: Dietary Supplement: Diet

• Registration Number: NCT03205904
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2016-12-12
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-07-02
• Primary Completion: 2019-02-20
• Study Completion: 2019-02-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Diet	Group that will be receive the diet

Primary Outcome Measures

Name	Time	Method
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase	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 Outcome Measures

Name	Time	Method
To evaluate anthropometric data of the patients before and after the intervention.	3 months	Improvement of nutritional status Using weight (kg) and height (cm) and BMI.
Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention	3 months	Evaluate the response of FEV 1 (forced expiratory volume) before and after the intervention
Evaluate the levels of HbA1c before and after the intervention	3 months	Evaluate the levels of HbA1c before and after the intervention

Trial Locations

Locations (1)

Ticiana da Costa Rodrigues; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil