Redox Imbalance and the Development of Cystic Fibrosis Diabetes
NCT02202876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2020-06-04
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
Conditions
- Diabetes Mellitus, Type 2
- Cystic Fibrosis
Interventions
- OTHER
-
Oral Glucose Tolerance Test
1.75 gm/kg to a maximum of 75 gm of an oral glucose solution
- 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
- 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
- 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.
- 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
Sponsors & Collaborators
-
Cystic Fibrosis Foundation
collaborator OTHER -
Emory University
lead OTHER
Principal Investigators
-
Arlene Stecenko, MD · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2018-09-09
- Completion
- 2018-09-09
Countries
- United States
Study Locations
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