Redox Imbalance and the Development of Cystic Fibrosis Diabetes

NCT02202876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-06-04

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202876 on ClinicalTrials.gov