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Completed NCT07251504

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

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 30 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 146
Sponsor: University of Cadiz

Location: Science of Education Faculty Puerto Real Cádiz

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.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of T2D or prediabetes (glycated hemoglobin ≥ 5.7%) * No history of substance abuse (tobacco, alcohol, or other drugs). * Body mass index ≥25 kg/m², maintaining the habitual dietary patterns with stable body weight for at the least 6 months * Stable physical activity and medication regimen for at least 6 months * Not insulin-dependent * Absence of injury, disease, disability, or other known medical condition which could affect the ability to successfully participate in physical exercise tests * Absence of tumours and cancer disease * Absence of other pathologies that could affect the study outcomes. * Not under medication regimen that could affect the study outcomes. * Being able to understand a communication in Spanish or English. * Not pregnant Exclusion Criteria: * Failure to attend more than 2 consecutive or a total of 4 sessions of nutritional intervention. * Failure to attend more than 4 consecutive or a total of 6 sessions of physical training. * Serious injury * Voluntary withdrawal * Increased dose of diabetes medication

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07251504). StuddyBuddy aggregates publicly available trial information.