Clinical Trial

Mitochondrial Metabolism and Oxidative Stress in Function of the Physical Exercise and Nutritional Counseling in T2DM

Study acronym: MITOX
Completed
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Summary
The goal of this randomized controlled trial is to learn about the effects of different aerobic modalities (moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT)) and diet on mitochondrial properties and oxidative stress in patients with type 2 diabetes (T2D). It will also learn about the different effects of these interventions in men and women. The main questions it aims to answer are: * What is the isolated and combined effect of these exercise modalities and diet? Is there a superior approach for mitochondrial metabolism and oxidative stress in patients with T2D? * Is there a sex-specific best combination choice for these different interventions? * Is there any relation between exercise and diet-induced changes in mitochondrial properties and oxidative stress and other health-related outcomes such as body composition or insulin sensitivity? To answer these questions, researchers designed a two-factor study. One factor was exercise, which had three levels (MICT, HIIT, and the inactive (INACT) condition). The second factor was diet, with two levels (Diet (D) and no diet (ND)). Hence, participants were randomly allocated into 6 groups: INACT-ND, INACT-D, MICT-ND, MICT-D, HIIT-ND, and HIIT-D. Participants did: * Underwent a 12-week intervention within the condition of his/her group * Visit the research group facilities three times per week if in an exercise group or once every two weeks if in a diet group.
Protocol Amendment History 1 change
critical Trial completed 2026-07-29
Trial Details
NCT Number NCT07251504
Lead Sponsor University of Cadiz
Collaborators: Instituto de investigación e innovación biomédica de Cádiz
Conditions Diabetes Mellitus, Type 2
Enrollment 146 participants
Start Date 2022-03-10
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28