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AzTrials

Diabetes Mellitus, Type 2MITOXNCT07251504

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

A study testing Nutritional intervention, The High-Intensity Interval Training (HIIT) and The Moderate-Intensity Continuous Training (MICT) in people with Diabetes Mellitus, Type 2, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this ancillary study 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 prediabetes or type 2 diabetes (T2D), and overweight or… Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Nutritional intervention, The High-Intensity Interval Training (HIIT) and The Moderate-Intensity Continuous Training (MICT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteSpain
Study dates
10 Mar 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 habitual dietary patterns with stable body weight for at least 6 months
  • Stable physical activity and medication regimen for at least 6 months
  • Lack of habitual vigorous-intensity physical activity and the presence of sedentary behavior characterized by prolonged sitting time (screened using the International Physical Activity Questionnaire short form).
  • Not insulin-dependent
Show all 12Show fewer
  • Absence of injury, disease, disability, or other known medical condition which could affect the ability to successfully participate in physical exercise tests
  • Absence of tumors and cancer disease
  • Absence of other pathologies that could affect the study outcomes.
  • Not on a medication regimen that could affect the study outcomes.
  • Being able to understand communication in Spanish or English.
  • Not pregnant

Who cannot join

  • Failure to attend more than 2 consecutive sessions 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Science of Education Faculty

    Puerto Real, Cádiz, 11510

Other trials in Spain

About this study

Official title: Mitochondrial Metabolism and Oxidative Stress in Function of the Type of Physical Exercise and Nutritional Counseling in Type 2 Diabetes Mellitus

The goal of this ancillary study 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 prediabetes or type 2 diabetes (T2D), and overweight or obesity. 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?
Read more

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.
Read the detailed description

This is an ancillary study of a randomized controlled trial (The APETEX study [NCT05259449]) conducted in the Province of Cádiz (Spain). The sample size for this ancillary study was determined by the calculation performed for the parent trial.

A total of 146 participants were enrolled and underwent baseline assessment of the study outcomes. Just after the baseline determination, participants were randomly allocated to one of the aforementioned study groups. The randomization process was stratified by sex, which means that approximately 50% of participants in each group were women. All participants received detailed written and verbal information about the study objectives, procedures, benefits, and potential risks before providing written informed consent. This study adhered to the principles of the Declaration of Helsinki and was approved by the Provincial Research Ethics Committee of Cádiz and the Coordinating Committee of Biomedical Research Ethics of Andalucía (registration number 92.21; PEIBA number 1026-N-21; internal codes SICEIA-2025-001870 and SICEIA-2025-000778).

At both baseline and post-intervention, participants were scheduled in the morning following an overnight fast of 8-10 hours. They were instructed to maintain their usual lifestyle, abstain from alcohol and caffeine for 24 hours, and avoid strenuous physical activity for at least 48 hours prior to testing. Procedures included body composition assessment through electrical bioimpedance, a vastus lateralis muscle biopsy, fasting blood collection, and an oral glucose tolerance test (OGTT) by ingesting 75 grams of glucose and blood draws at 30, 60, 90, 120, 150, and 180 minutes post-ingestion. The same protocol was repeated after the 12-week intervention, with exercise groups completing their final training session at least 48 hours before the post-intervention assessments (range: 48 - 72 hours).

Being tested
Nutritional intervention, The High-Intensity Interval Training (HIIT), The Moderate-Intensity Continuous Training (MICT)
Keywords
metabolic disorders, aerobic exercise, muscle metabolism, high-resolution respirometry
Medical subject headings
Diabetes Mellitus, Type 2, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional interventionBehavioural

    The nutritional intervention was conducted through biweekly (± 3 days) in-person consultations with a nutritionist or dietitian. Firstly, the patient's diet was analyzed. Then, participants were guided to follow a mildly calorie-restricted diet (-250-500 kcal/day deficit), with the primary goal of achieving a 5 % reduction in body weight and reducing blood glucose levels. Meal plans were created using Nutrium® software , personalized to each participant's lifestyle and food preferences, and reviewed at each biweekly consultation. The dietary plan included at least 4 or 5 meals per day, ensuring a well-distributed intake of carbohydrates, a balanced distribution of macro- and micronutrients, and the inclusion of foods rich in prebiotics and probiotics. Moreover, some suggestions about the combination of foods and culinary techniques were provided. Only one session through the intervention was allowed to be attended telephonically.

  • The High-Intensity Interval Training (HIIT)Other

    Participants assigned to the HIIT completed 3 weekly sessions, with 1-2 days of rest between sessions, on a cycle ergometer for 12 weeks.

    The training load (TL) was determined from an incremental test until volitional exhaustion with one-minute work intervals (from 85% to 165% of maximal power output from a previously performed VO2max test [Wmax] and with 10% increments) separated by 1.5-minute rest periods (at 20% Wmax).

    The program consisted of a 3 minutes warm-up with the first 2 minutes at 20% and last minute at 40% of the TL, followed by 10 series of 1 min duration at 90% of TL, with 1 minute of rest between sets at 20% of TL and ending with 2 minutes of cool-down at 20% of TL (estimated total time of the session: 25 minutes). A 5% increase in workload was applied when, for two consecutive sessions, the first three intervals failed to exceed 85%, and at least five did not reach 90% of maximal HR. Participants were asked to maintain a cadence above 80RPM.

  • The Moderate-Intensity Continuous Training (MICT)Other

    Participants assigned to the MICT completed 3 weekly sessions, with 1-2 days of rest between sessions, on a cycle ergometer for 12 weeks.

    MICT consisted of 50 minutes of continuous pedaling at an intensity approximately 10 % above the lactate threshold, with a cadence between 60-80 rpm. Training load (TL) was increased by 10% if these two conditions were met: 1) no increase of at least 2 beats of heart rate from minute 20 to minute 40 of the training session, and 2) lactate levels below 2 mmol/L in minute 48 of the session. The TL for the first session was determined by an adjustment test consisting of an incremental test with five consecutive 10-minute phases at a constant cadence (60-80 RPM) from 90% to 130% of the ventilatory threshold power, calculated from previously performed FatOx test data, with 10% increments in each step. TL was determined by the phase in which HR increased by ≥ 3 beats between phases and blood lactate levels increased by ≥ 1 mmol/L from the previous phase.

Study groups in NCT07251504
Study groupRoleWhat they receive
ND-INACTNo interventionParticipants who did not receive either nutritional intervention or exercise program. They were instructed to maintain their normal life habits regarding physical activity and diet.
Moderate-intensity continuous training (ND-MICT)Active comparatorParticipants who did not receive nutritional intervention but were enrolled in a moderate-intensity continuous training exercise program.
Receives: Other: The Moderate-Intensity Continuous Training (MICT)
High-intensity interval training (ND-HIIT)Active comparatorParticipants who did not receive nutritional intervention but were enrolled in a high-intensity interval training exercise program.
Receives: Other: The High-Intensity Interval Training (HIIT)
Nutritional intervention (D-INACT)Active comparatorParticipants who received nutritional intervention but not an exercise program.
Receives: Behavioral: Nutritional intervention
Nutritional Intervention Moderate-Intensity continuous training (D-MICT)ExperimentalParticipants who received nutritional intervention and were enrolled in a moderate-intensity continuous training exercise program.
Receives: Behavioral: Nutritional intervention; Other: The Moderate-Intensity Continuous Training (MICT)
Nutritional Intervention High-intensity interval training (D-HIIT)ExperimentalParticipants who received nutritional intervention and were enrolled in a high-intensity interval training exercise program.
Receives: Behavioral: Nutritional intervention; Other: The High-Intensity Interval Training (HIIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle biopsy samples: mitochondrial respiratory capacity

    Skin was locally anesthetized, followed by an incision of approximately 6-7mm on the dermal surface. Using sterilized Bergstrom needles, approximately 3-6 mg of skeletal muscle from the lateral vastus were extracted and placed in a BIOPS buffer for immediate analysis of mitochondrial respiration (MR) through high-resolution respirometry. Before, the fibers were mechanically separated in BIOPS buffer using sterilized needles and chemically permeabilized with a 50 μg/ml saponin solution.

    MR was measured in a specific buffer (Mir05) in duplicate in hyperoxygenated chambers (250-450 nmol/mL of oxygen) in an Oxygraph-2k at 37ºC (Oroboros, Innsbruck, Austria). A substrate-uncoupler titration protocol was employed by adding (final concentration): malate (2mM), pyruvate (5mM), glutamate (2mM), MgCl2 (3mM), and ADP (5mM), cytochrome C (10μM), succinate (10mM), and p-trifluoromethoxyphenylhydrazone. Oxygen flux was presented as mass-specific (pmol·s/mg wet weight) and normalized to CS activity.

    Measured: Pre and post the 12-week intervention

  2. Assessed changes in Oxidative Stress

    The level of oxidative stress was assessed by the concentration of 8-OHdG as a biomarker of DNA oxidation. A competitive ELISA detection method was employed in serum samples. Briefly, the standard and the sample were added to a pre-coated microplate along with the biotinylated detection antibody. After washing, HRP-Streptavidin was added. Then, the TMB substrate was added, and the reaction was terminated with an acid solution. The color production was measured spectrophotometrically at a wavelength of 450nm. The optical density values of samples were compared with those of the standard curve to determine the 8-OHdG concentration (ng/ml).

    Measured: Pre and post the 12-week intervention

  3. Muscle biopsy sample: Citrate Synthase activity

    2-5 mg of frozen muscle was homogenized in a 1:20 dilution of CelLytic™ MT Tissue Lysis (C3228, Sigma-Aldrich, Dorset, UK), with 1 % protease inhibitor cocktail (P8340, Sigma-Aldrich, Dorset, UK) at 4 °C. The lysate was centrifuged at 12,000 × g for 10 min at 4 °C to pellet debris, and the supernatant was stored at -80 °C. CS activity was quantified in duplicates using an assay kit following the manufacturer's instructions (CS0720: Sigma-Aldrich, Dorset, UK). Briefly, endogenous activity was recorded through color emission by DTNB, and total activity was calculated after the addition of oxalacetate. Protein concentration was determined in duplicates using a bicinchoninic acid assay kit (BCA1: Sigma-Aldrich, Dorset, UK), enabling normalization of CS activity values to total protein content (µmol/g/min). CS activity and protein concentration were measured in 96-well plates using a microplate reader at 412 nm and 562 nm, respectively (MQX200R2, Biotek instruments, Burlington, USA).

    Measured: Pre and post the 12-week intervention

Secondary outcomes (27)

  1. Assessed changes in Glucose concentration

    Glucose concentration (mg/dL) was measured from blood samples collected from the antecubital vein after at least 8 hours of fasting and at 30, 60, 90, 120, 150, and 180 minutes after the ingestion of 75 grams of glucose (Nuter-tec, 75 g/200 mL, orange flavor). Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine consumption for 24 hours, and avoid vigorous physical activity for at least 48 hours. Blood samples were centrifuged and plasma was analyzed using the colorimetric method performed on the Alinity CI system (Abbott Laboratories, Abbott Park, IL, USA).

    Measured: Pre and Post the 12-week intervention

  2. Assessed changes in Insulin concentration

    Insulin concentration (µU/mL) was measured from blood samples collected from the antecubital vein into serum separator tubes after at least 8 hours of fasting and at 30, 60, 90, 120, 150, and 180 minutes after the ingestion of 75 grams of glucose (Nuter-tec, 75 g/200 mL, orange flavor). Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine consumption for 24 hours, and avoid vigorous physical activity for at least 48 hours. Blood samples were centrifuged at 4000 rpm for 7 minutes, and serum was analyzed. Insulin concentrations were determined by chemiluminescent immunoassays performed on the Alinity CI system (Abbott Laboratories, Abbott Park, IL, USA).

    Measured: Pre and Post the 12-week intervention

  3. Assessed changes in Insulin Resistance: HOMA-IR

    Insulin resistance was estimated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated as fasting insulin (µU/mL) multiplied by fasting glucose (mg/dL) divided by 405.

    Measured: Pre and Post 12-week intervention

  4. Assessed changes in Tissue Oxygenation Index

    A NIRO-200NX device was used to measure skeletal muscle tissue oxygenation index (%) through near-infrared spectroscopy (NIRS), the modified Beer-Lambert law (MBLL), and spatially resolved spectroscopy. The NIRS sensor (emitter-sensor distance of 3cm) was placed at two-thirds of the distance from the anterior superior iliac spine to the superolateral patellar border, over the vastus lateralis muscle belly. The NIRS data were continuously acquired throughout a resting energy expenditure test for 30 minutes, a maximal fat oxidation (MFO) test on a cycloergometer, and a maximal oxygen consumption (VO2max) test on a cycloergometer. Briefly, the MFO test consisted of an incremental task with 3-minute phases starting from 15W and increasing by 15W each phase until a respiratory exchange ratio of 1. After a 5-minute rest, the VO2max test was initiated at last MFO load with 15W increases each minute until VO2max determination.

    Measured: Pre and post the 12-week intervention

  5. Assessed changes in haemoglobin saturation delta

    A NIRO-200NX device was used to measure skeletal muscle changes on oxygenated, desoxygenated, and total haemoglobin (μmol/L) through near-infrared spectroscopy (NIRS) and the modified Beer-Lambert law. The NIRS sensor (emitter-sensor distance of 3cm) was placed at two-thirds of the distance from the anterior superior iliac spine to the superolateral patellar border, over the vastus lateralis muscle belly. The NIRS data were continuously acquired throughout a resting energy expenditure test for 30 minutes, a maximal fat oxidation (MFO) test on a cycloergometer, and a maximal oxygen consumption (VO2max) test on a cycloergometer. Briefly, the MFO test consisted of an incremental task with 3-minute phases starting from 15W and increasing by 15W each phase until a respiratory exchange ratio of 1. After a 5-minute rest, the VO2max test was initiated at last MFO load with 15W increases each minute until VO2max determination.

    Measured: Pre and post the 12-week intervention

  6. Assessed changes in Insulin Sensitivity: Matsuda Index

    Whole body insulin sensitivity was estimated through the Matsuda Index, calculated as 10,000 / √[(fasting glucose (mg/dL) × fasting insulin (µU/mL)) × (mean glucose during Oral Glucose Tolerance Test (mg/dL) × mean insulin during Oral Glucose Tolerance Test (µU/mL))].

    Measured: Pre and Post 12-week intervention

  7. Assessed changes in Insulin Sensitivity: Quicki

    Insulin sensitivity was estimated through the Quantitative Insulin Sensitivity Check Index (QUICKI), calculated as 1 / [log(fasting insulin (µU/mL)) + log(fasting glucose (mg/dL))].

    Measured: Pre and Post 12-week intervention

  8. Assessed changes in Body Weight

    Body weight (kilograms, kg) was measured using a multifrequency bioelectrical impedance device (TANITA-MC780MA, Tanita Corp., Tokyo, Japan) after at least 8 hours of fasting. Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine for 24 hours, and avoid vigorous physical activity for at least 48 hours. Participants wore light clothing and were asked to urinate immediately before the measurement.

    Measured: Pre and Post the 12-week intervention

  9. Assessed Height

    Height (meters, m) was measured using a wall-mounted stadiometer (TANITA-LEICESTER HR-001, Tanita Corp., Tokyo, Japan) with participants standing in accordance with the manufacturer's instructions.

    Measured: Pre and Post 12-week Intervention

  10. Assessed changes in Body Mass Index

    Body Mass Index (BMI) in kilograms per square meter (kg/m²) was calculated as body weight (kg) divided by height squared (m²).

    Measured: Pre and Post 12-week Intervention

  11. Assessed changes in Fat Mass (kilograms of Fat Mass)

    Fat mass (kilograms, kg) was estimated using multifrequency bioelectrical impedance with an 8-electrode device (TANITA-MC780MA, Tanita Corp., Tokyo, Japan) after at least 8 hours of fasting. Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine for 24 hours, and avoid vigorous physical activity for at least 48 hours. Participants wore light clothing and were asked to urinate immediately before the measurement.

    Measured: Pre and Post 12-week Intervention

  12. Assessed changes in Fat Mass (percentage of Fat Mass)

    Fat mass (percentage of total body weight, %) was estimated using multifrequency bioelectrical impedance with an 8-electrode device (TANITA-MC780MA, Tanita Corp., Tokyo, Japan) after at least 8 hours of fasting. Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine for 24 hours, and avoid vigorous physical activity for at least 48 hours. Participants wore light clothing and were asked to urinate immediately before the measurement.

    Measured: Pre and Post 12-week Intervention

  13. Assessed changes in Fat-free Mass (kilograms of Fat-free Mass)

    Fat-free mass (kilograms, kg) was estimated using multifrequency bioelectrical impedance with an 8-electrode device (TANITA-MC780MA, Tanita Corp., Tokyo, Japan) after at least 8 hours of fasting. Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine for 24 hours, and avoid vigorous physical activity for at least 48 hours. Participants wore light clothing and were asked to urinate immediately before the measurement.

    Measured: Pre and Post 12-week Intervention

  14. Assessed changes in Fat-free Mass (percentage of Fat-free Mass)

    Fat-free mass (percentage of total body weight, %) was estimated using multifrequency bioelectrical impedance with an 8-electrode device (TANITA-MC780MA, Tanita Corp., Tokyo, Japan) after at least 8 hours of fasting. Participants were instructed the day before testing to maintain their usual lifestyle, refrain from alcohol or caffeine for 24 hours, and avoid vigorous physical activity for at least 48 hours. Participants wore light clothing and were asked to urinate immediately before the measurement.

    Measured: Pre and Post 12-week Intervention

  15. Assessed changes in Anthropometry: Perimeters

    Waist circumference (cm) was measured at the midpoint between the lower lateral margin of the 10th rib and the iliac crest, perpendicular to the longitudinal axis of the trunk. Abdominal circumference (cm) was measured at the level of the umbilicus, perpendicular to the longitudinal axis of the trunk. Hip circumference (cm) was measured at the level of the greatest posterior prominence of the buttocks, perpendicular to the longitudinal axis of the trunk. Thigh circumference (cm) was measured at the midpoint between the greater trochanter and the lateral tibial condyle. All measurements were performed with the participant standing upright, and relaxed. Each measurement was taken twice, and a third measurement was performed if the difference exceeded 1%. The mean of the two most similar records was registered.

    Measured: Pre and Post 12-week Intervention

  16. Assessed changes in Anthropometry: Waist to Hip Ratio

    Waist-to-hip ratio (WHR) was calculated as waist circumference (cm) divided by hip circumference (cm).

    Measured: Pre and Post 12-week Intervention

  17. Assessed changes in Anthropometry: Skinfold thickness

    Thigh skinfold thickness was measured at two-thirds of the distance from the iliospinale point (the lowest part of the anterior superior iliac spine) to the superolateral border of the patella, over the belly of the vastus lateralis muscle. Measurements were taken on the dominant leg. Two measurements were obtained, and a third was taken if the difference between the first two exceeded 1mm. The mean of the two most similar records was recorded.

    Measured: Pre and Post 12-week Intervention

  18. Assessed changes in interleukin-6

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum interleukin-6 (pg/mL) was measured by electrochemiluminescence immunoassay using a Cobas e 411 (Roche Diagnostics, Mannheim, Germany).

    Measured: Pre and Post the 12-week intervention

  19. Assessed changes in C-reactive protein

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum C-reactive protein (mg/L) was determined by immunoturbidimetric assay on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  20. Assessed changes in alanine aminotransferase

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum alanine aminotransferase (U/L) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  21. Assessed changes in aspartate aminotransferase

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum aspartate aminotransferase (U/L) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  22. Assessed changes in gamma-glutamyl transferase

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum gamma-glutamyl transferase (U/L) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  23. Assessed changes in tumor necrosis factor-alpha

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® EDTA K2 separator tubes (Greiner Bio-One, Kremsmünster, Austria) to obtain plasma. Plasma was aliquoted into 500 µL tubes with 5 µL protease inhibitors, then stored at -80 °C. Plasma tumor necrosis factor-alpha (pg/mL) was measured using multiplex magnetic bead-based immunoassays (MILLIPLEX® Metabolic Hormone Panel V3, HMH3-34K-06, Merck Millipore, Darmstadt, Germany) and analyzed with a Luminex® xMap IntelliFlex System (Luminex Corp., Austin, TX, USA).

    Measured: Pre and Post the 12-week intervention

  24. Assessed changes in triglycerides

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum triglycerides (mg/dL) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  25. Assessed changes in total cholesterol

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum total cholesterol (mg/dL) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  26. Assessed changes in high-density lipoprotein

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum high-density lipoprotein (mg/dL) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

  27. Assessed changes in low-density lipoprotein

    Blood drawing was performed with participants in a fasting state for 8-10 hours and scheduled in the morning. Before blood drawing, participants were instructed to maintain their usual lifestyle, avoid alcohol and caffeine for 24 hours, and refrain from vigorous physical activity for at least 48 hours. Blood was collected by peripheral venepuncture using VACUETTE® blood serum separator tubes (Greiner Bio-One, Kremsmünster, Austria). Serum low-density lipoprotein (mg/dL) was determined by enzymatic spectrophotometric assays on the Alinity C analyzer (Abbott Laboratories, Abbott Park, Illinois, USA).

    Measured: Pre and Post the 12-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start10 Mar 2022
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The project is a randomized controlled trial in individuals with prediabetes or type 2 diabetes, and overweight or obesity
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07251504
Sponsor's protocol ID
MITOX
Other IDs
PP11-007-2023
Acronym
MITOX
Status last verified
Sep 2026
First submitted
26 Sep 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional intervention, The High-Intensity Interval Training (HIIT) and The Moderate-Intensity Continuous Training (MICT) in people with Diabetes Mellitus, Type 2, run by University of Cadiz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle biopsy samples: mitochondrial respiratory capacity (time frame: Pre and post the 12-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07251504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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