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Exercise to preserve beta cell function in recent-onset type 1 diabetes mellitus (EXTOD)--a study protocol for a
Nadia Lascar1, Amy Kennedy, Nikki Jackson
1Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
Trials
|June 20, 2013
Summary
This study explores exercise benefits for newly diagnosed type 1 diabetes patients. It aims to gather data for a larger trial on exercise and beta cell preservation in type 1 diabetes.
Area of Science:
- Endocrinology
- Exercise Physiology
- Diabetes Research
Background:
- Exercise demonstrates beta cell preserving effects in type 2 diabetes.
- The impact of exercise on beta cell preservation in type 1 diabetes remains unexamined.
- Newly diagnosed type 1 diabetes patients retain significant beta cell function, making them ideal for preservation studies.
Purpose of the Study:
- To gather essential data for designing a formal study on exercise and beta cell preservation in new-onset type 1 diabetes.
- To identify barriers and facilitators to exercise participation in this population.
- To inform the methodology for future clinical trials.
Main Methods:
- A qualitative assessment of exercise barriers in newly diagnosed patients.
- Randomization of 60 adult type 1 diabetes patients to conventional treatment or an exercise intervention (150-240 min/week for 12 months).
- Measurement of beta cell function via meal-stimulated C-peptide; primary outcomes include recruitment, adherence, and contamination.
Main Results:
- The study will define barriers to exercise in newly diagnosed type 1 diabetes.
- It will assess patient uptake and adherence to an exercise regimen.
- It will provide data on exercise levels and potential contamination in the control group.
Conclusions:
- The EXTOD study outcomes will inform the design of a definitive trial.
- It will clarify the role of exercise in preserving beta cell function in new-onset type 1 diabetes.
- This research is crucial for optimizing management strategies for type 1 diabetes.
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