Redox Imbalance and the Development of Cystic Fibrosis Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02202876
• Date of registration: 25/07/2014
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Redox Imbalance and the Development of Cystic Fibrosis Diabetes Redoxy
• Scientific title: Redox Imbalance and the Development of Cystic Fibrosis Diabetes
• Date of first enrolment: November 2014
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02202876
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Arlene Stecenko, MD
• Affiliation: Emory University

Key inclusion & exclusion 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



Age minimum: 1 Year
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Cystic Fibrosis

Intervention(s)

Other: Fruit juice

Other: High Glycemic Index Meal

Other: Low Glycemic Index Meal

Other: Oral Glucose Tolerance Test

Other: Test Soda

Primary Outcome(s)

Acute oxidation [Time Frame: Up to three hours]

Secondary ID(s)

IRB00060962

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation