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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03205904
• Other study ID #: 160206
• Status: Completed
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: February 20, 2019

Study information

• Verified date: January 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis-related Diabetes
• Fibrosis
• Prediabetic State

Intervention

Dietary Supplement:
• Diet
Nutrition booklet with guidelines on types of fats and glycemic index

Locations

Country	Name	City	State
Brazil	Ticiana da Costa Rodrigues	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the levels of HbA1c before and after the intervention	Evaluate the levels of HbA1c before and after the intervention	3 months
Secondary	Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention	Evaluate the response of FEV 1 (forced expiratory volume) before and after the intervention	3 months
Secondary	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