Redox Imbalance and the Development of Cystic Fibrosis Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2, Cystic Fibrosis

In brief

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

Key facts

Study ID

NCT02202876

Run by

Emory University

People needed

34

Starts

2014-11-01

Expected to finish

2018-09-09

Last updated by the study team

2020-06-04

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Healthcare of Atlanta and Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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