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

Primary Purpose

Cystic Fibrosis-related Diabetes, Cystic Fibrosis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Diet

About this trial

This is an interventional prevention trial for Cystic Fibrosis-related Diabetes focused on measuring cystic fibrosis related diabetes

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ticiana da Costa Rodrigues

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

control

Arm Description

Group that will be receive the diet

Group that will not receive the diet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the levels of HbA1c before and after the intervention

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

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

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

Full Information

NCT ID

NCT03205904

First Posted

June 15, 2017

Last Updated

January 12, 2021

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT03205904

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

December 12, 2016 (Actual)

Primary Completion Date

February 20, 2019 (Actual)

Study Completion Date

February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis-related Diabetes, Cystic Fibrosis

Keywords

cystic fibrosis related diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

Group that will be receive the diet

Arm Title

control

Arm Type

No Intervention

Arm Description

Group that will not receive the diet

Intervention Type

Dietary Supplement

Intervention Name(s)

Diet

Intervention Description

Nutrition booklet with guidelines on types of fats and glycemic index

Primary Outcome Measure Information:

Title

glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase

Description

To evaluate the improvement of glucose levels after the diet intervention. After 12 weeks of intervention will be performed oral glucose tolerance test

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Evaluate the levels of HbA1c before and after the intervention

Description

Evaluate the levels of HbA1c before and after the intervention

Time Frame

3 months

Title

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

Description

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

Time Frame

3 months

Title

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

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ticiana C Rodrigues, Doctor

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ticiana da Costa Rodrigues

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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