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Completed

NCT Number: NCT03205904

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

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Key information

Conditions

Cystic Fibrosis-related Diabetes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ticiana da Costa Rodrigues

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Dietary Supplement

Nutrition booklet with guidelines on types of fats and glycemic index

Primary outcomes

  1. 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

  1. Evaluate the levels of HbA1c before and after the intervention

    Time frame: 3 months

    Evaluate the levels of HbA1c before and after the intervention

  2. Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention

    Time frame: 3 months

    Evaluate the response of FEV 1 (forced expiratory volume) before and after the intervention

  3. To evaluate anthropometric data of the patients before and after the intervention.

    Time frame: 3 months

    Improvement of nutritional status Using weight (kg) and height (cm) and BMI.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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