Mitochondrial Metabolism and Oxidative Stress in Function of the Physical Exercise and Nutritiona… (NCT07251504) | Clinical Trial Compass
CompletedNot Applicable
Mitochondrial Metabolism and Oxidative Stress in Function of the Physical Exercise and Nutritional Counseling in T2DM
Spain146 participantsStarted 2022-03-10
Plain-language 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.
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial took muscle biopsies to look at mitochondrial function and oxidative stress in people with Type 2 diabetes — based on what it found, does the combination of exercise and nutritional counseling show any signals of improving how my muscles use oxygen, and is that relevant to where I am in managing my diabetes?
2Since this trial is now completed, has any data been published or shared yet, and could you help me understand what the findings about mitochondrial respiratory capacity and citrate synthase activity might mean for someone in my situation?
3The trial measured oxidative stress alongside physical exercise and diet changes — are there any safety considerations I should know about, such as whether intense exercise could actually increase oxidative stress in someone with Type 2 diabetes before it gets better?
4Given that this study used muscle biopsies as a key measurement tool, how invasive and realistic would that kind of monitoring be outside of a research setting, and does it change how you'd recommend I pursue exercise or dietary changes in my own care plan?
5Would the type of exercise and nutritional counseling used in this trial be something we could incorporate into my current treatment plan, or would a more standard diabetes management approach be a better starting point for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.