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

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ClinicalTrials.gov Identifier: NCT03205904
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis-related Diabetes Cystic Fibrosis Dietary Supplement: Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : November 20, 2018
Estimated Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group
Group that will be receive the diet
Dietary Supplement: Diet
Nutrition booklet with guidelines on types of fats and glycemic index

No Intervention: control
Group that will not receive the diet



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205904


Contacts
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Contact: Ticiana C Rodrigues, Doctor 55 51 33597640 ticianacr@yahoo.com.br
Contact: Raquel E Prates Freiberg, student 55 51 33597640 raqueccel@gmail.com

Locations
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Brazil
Ticiana da Costa Rodrigues Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Raquel E Prates Freiberg, Student    5551984080375    raqueccel@gmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ticiana C Rodrigues, Doctor Hospital de Clinicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03205904     History of Changes
Other Study ID Numbers: 160206
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
cystic fibrosis related diabetes
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Prediabetic State
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases