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Redox Imbalance and the Development of Cystic Fibrosis Diabetes (Redoxy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202876
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Arlene Stecenko, Emory University

Brief Summary:

Cystic fibrosis-related diabetes (CFRD) occurs in almost 20% of teens and 50% of adults. The investigators' long term goal is to determine the cause of CFRD in order to translate this knowledge into therapies aimed at preventing CFRD. Since CFRD and type 2 diabetes share several clinical features and since oxidative stress is a key factor in the development of type 2 diabetes, the investigators explored the role of oxidative stress in CFRD. The investigators discovered a unique CF biochemical signature that they believe could be implicated in the development of CFRD. The investigators found that glucose ingestion in CF teens and young adults causes an acute and profound systemic redox imbalance to the oxidizing state. The degree of redox imbalance was quite severe and would be expected to damage the insulin producing cells as these cells are particularly vulnerable to oxidative stress. Thus, these findings could prove to be a critical factor in the pathogenesis of CFRD. This proposal will test the hypothesis that glucose-induced redox imbalance is an intrinsic, metabolic defect in CF. In addition, because CF people are required to consume a high calorie diet to maintain their weight, the investigators also hypothesize that certain high caloric foods will recapitulate the redox imbalance induced by ingesting glucose and thus hasten the development of CFRD. Specifically, the investigators aim to:

  • Determine whether young children with CF have glucose-induced redox imbalance
  • Determine whether eating a meal with a high glycemic index induces acute redox imbalance
  • Determine whether commonly consumed beverages containing simple sugars (i.e., soda or fruit juice) induce acute redox imbalance

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Cystic Fibrosis Other: Oral Glucose Tolerance Test Other: High Glycemic Index Meal Other: Low Glycemic Index Meal Other: Test Soda Other: Fruit juice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Redox Imbalance and the Development of Cystic Fibrosis Diabetes
Actual Study Start Date : November 2014
Actual Primary Completion Date : September 9, 2018
Actual Study Completion Date : September 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Active Comparator: Aim 1: Children with Cystic Fibrosis
Cystic Fibrosis children aged 1 to 9 years with normal glucose tolerance receiving Oral Glucose Tolerance Test
Other: Oral Glucose Tolerance Test
1.75 gm/kg to a maximum of 75 gm of an oral glucose solution
Other Name: OGTT

Active Comparator: Aim 1: Control Children
Children with out Cystic Fibrosis aged 1 to 9 years controls with normal glucose tolerance receiving Oral Glucose Tolerance Test
Other: Oral Glucose Tolerance Test
1.75 gm/kg to a maximum of 75 gm of an oral glucose solution
Other Name: OGTT

Active Comparator: Aim 2a: Teens with Cystic Fibrosis - High Glycemic Meal
Cystic Fibrosis subjects 12 years of age or older with normal glucose tolerance eating High Glycemic Index Meal
Other: High Glycemic Index Meal

isocaloric breakfasts - set the high glycemic index to 80

The nutrient composition of each meal will be 10 kcal per kg, 50% kcal from carbohydrates, 20% kcal from protein, and 30% kcal from fat


Active Comparator: Aim 2a: Teens with Cystic Fibrosis - Low Glycemic Meal
Cystic Fibrosis subjects 12 years of age or older with normal glucose tolerance eating Low Glycemic Index Meal
Other: Low Glycemic Index Meal

isocaloric breakfasts - set the low glycemic index to 30

The nutrient composition of each meal will be 10 kcal per kg, 50% kcal from carbohydrates, 20% kcal from protein, and 30% kcal from fat


Active Comparator: Aim 2b: Cystic Fibrosis Consuming Test Soda
Participants with Cystic Fibrosis 12 years of age or older with normal glucose tolerance or impaired glucose tolerance consuming a test beverage of a test soda. A week later these participants will have an Oral Glucose Tolerance Test.
Other: Oral Glucose Tolerance Test
1.75 gm/kg to a maximum of 75 gm of an oral glucose solution
Other Name: OGTT

Other: Test Soda
Test soda containing 60% fructose and 40% glucose at a dose of 1.75 grams per kilogram body weight to a maximum of 75 grams.

Active Comparator: Aim 2b: Cystic Fibrosis Consuming Fruit Juice
Participants with Cystic Fibrosis 12 years of age or older with normal glucose tolerance or impaired glucose tolerance consuming a test beverage of fruit juice. A week later these participants will have an Oral Glucose Tolerance Test.
Other: Oral Glucose Tolerance Test
1.75 gm/kg to a maximum of 75 gm of an oral glucose solution
Other Name: OGTT

Other: Fruit juice
Fruit juice containing a combination fructose, glucose, and sucrose at a dose of 1.75 grams per kilogram body weight to a maximum of 75 grams




Primary Outcome Measures :
  1. Acute oxidation [ Time Frame: Up to three hours ]
    cysteine/cysteine ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Aim 1

Inclusion Criteria:

For CF children with class I-III mutations

  • CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
  • CFTR mutation analysis showing two Class I to III mutations
  • Aged 1-9 years
  • On a clinically stable medical regimen for at least three weeks
  • No IV or oral antibiotics for a respiratory exacerbation for at least three weeks
  • No hospitalization for at least six weeks

For CF children with class IV-VI mutations

  • CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
  • CFTR mutation analysis showing at least one Class IV-VI mutation
  • Aged 1-9 years
  • On a clinically stable medical regimen for at least three weeks
  • No IV or oral antibiotics for a respiratory exacerbation for at least three weeks
  • No hospitalization for at least six weeks
  • Not taking pancreatic enzyme replacement therapy

For age-matched controls

  • No acute illness for at least six weeks
  • Never been hospitalized except at birth following a full term delivery
  • Aged 1 to 9 years
  • Without any chronic illness requiring prescription medications

Exclusion Criteria:

  • Current or past diagnosis of CFRD (for CF children)
  • Parents unwilling to have an IV inserted for blood draws

Aim 2a

Inclusion Criteria:

  • CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
  • CFTR mutation analysis showing two Class I to III mutations
  • Aged 12 years or older
  • On a clinically stable medical regimen for at least three weeks
  • No IV or oral antibiotics for a respiratory exacerbation for at least three weeks

Exclusion Criteria:

  • Current or past diagnosis of CFRD
  • Allergy or intolerance to egg or dairy products

Aim 2b

Inclusion Criteria:

  • CF diagnosed by pilocarpine electrophoresis sweat test and/or CFTR genetic mutation analysis
  • CFTR mutation analysis showing two Class I to III mutations
  • Aged 12 years or older
  • On a clinically stable medical regimen for at least three weeks
  • No IV or oral antibiotics for a respiratory exacerbation for at least three weeks
  • Subjects who have or have not completed the redox meal challenge are allowed to participate

Exclusion Criteria:

  • Current or past diagnosis of CFRD
  • Allergy or intolerance to any component of the test beverage (i.e., soda, fruit juice) and glucola

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): NCT02202876


Locations
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United States, Georgia
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Arlene Stecenko, MD Emory University
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Responsible Party: Arlene Stecenko, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02202876    
Other Study ID Numbers: IRB00060962
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases