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NCT02202876 · ClinicalTrials.gov registry record · NA
Redox Imbalance and the Development of Cystic Fibrosis Diabetes
A NA study of Diabetes Mellitus, Type 2 and Cystic Fibrosis, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT02202876 is a NA study of Diabetes Mellitus, Type 2 and Cystic Fibrosis that has completed, run by Emory University. The registered enrollment target is 34 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02202876, a NA study of Diabetes Mellitus, Type 2 and Cystic Fibrosis, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Oral Glucose Tolerance Test
- OTHER High Glycemic Index Meal
- OTHER Low Glycemic Index Meal
- OTHER Test Soda
- OTHER Fruit juice
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta and Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-11 |
| Est. Completion | 2018-09-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02202876
The ClinicalTrials.gov registry entry for NCT02202876 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 5 interventions - of which Oral Glucose Tolerance Test is the first listed.
NCT02202876 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT02202876 about?
NCT02202876 is a clinical study titled "Redox Imbalance and the Development of Cystic Fibrosis Diabetes". 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 an...
What is the current status of trial NCT02202876?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2014-11. Estimated completion is 2018-09-09.
What conditions does trial NCT02202876 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Cystic Fibrosis.
What interventions are being tested in trial NCT02202876?
The interventions under investigation include: Oral Glucose Tolerance Test (OTHER), High Glycemic Index Meal (OTHER), Low Glycemic Index Meal (OTHER), Test Soda (OTHER), Fruit juice (OTHER).
Who is sponsoring clinical trial NCT02202876?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02202876 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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