Redox Imbalance and the Development of Cystic Fibrosis Diabetes (NCT02202876) | Clinical Trial Compass
CompletedNot Applicable
Redox Imbalance and the Development of Cystic Fibrosis Diabetes
United States34 participantsStarted 2014-11
Plain-language 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
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.