Clinical trial NCT03205904: Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
Official title: Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis-related Diabetes
Cystic Fibrosis
Keywords: cystic fibrosis related diabetes
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate the levels of HbA1c before and after the intervention
timeFrame: 3 months
measure: Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention
timeFrame: 3 months
measure: To evaluate anthropometric data of the patients before and after the intervention.
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Ticiana da Costa Rodrigues
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Ticiana C Rodrigues, Doctor
role: PRINCIPAL_INVESTIGATOR
References: