NCT05259449Completed
Efficacy of Educational Nutrition and Exercise on the Regulation of Appetite Through Exosomes in Type 2 Diabetics
Efficacy of a Nutritional Education Strategy and Role of Physical Exercise on the Regulation of Appetite and Body Composition Through the Profile of Exosomes in Type 2 Diabetics (The APETEX Project)
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
The aim of this randomized controlled trial is to investigate the effects of different aerobic modalities: moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT), and a nutritional intervention (D) on appetite regulation, appetite-related hormones, neural responses to food cues (EEG), and exosome-derived molecular signals in patients with prediabetes or type 2 diabetes (T2D), and overweight or obesity. It will also examine whether these effects differ between men and women. The main questions it aims to answer are: * What is the isolated and combined effect of these exercise modalities and diet on glucose metabolism, insulin dynamics, miRNA exosomal expression, appetite hormones, and neural responses to food stimuli? * Is there a sex-specific best combination choice for improving appetite regulation and metabolic control? * Are changes in miRNA exosomal profile, appetite-related hormones, and EEG-based neural responses associated with other health-related outcomes such as body composition, fat mass reduction, insulin sensitivity, physical condition, and quality of life? To answer these questions, researchers designed a two-factor study. One factor was diet, with two levels (Diet (D) and no diet (ND)). The second factor was exercise, with three levels (inactive (INACT), MICT, and HIIT). Participants were randomly allocated into six groups: ND-INACT, ND-MICT, ND-HIIT, D-INACT, D-MICT, D-HIIT. Participants did: * Underwent a 12-week intervention within their assigned group. * Visited the research facilities three times per week if assigned to an exercise group, or once every two weeks if in a diet group.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 17 Dec 2021
- Start date
- Mar 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- University of Cadiz
- Diseases
- Type 2 diabetes
- NCT number
- NCT05259449
What you commit to
- Study type: Interventional
- Participants enrolled: 146
- From Mar 2022 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Increased dose of diabetes medication
Other
- Serious injury
- Voluntary withdrawal
Who the study is looking for
- Diagnosis of type 2 diabetes or prediabetes (HbA1c ≥ 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 (screening using the International Physical Activity Questionnaire short form).
- 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 tumors 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 communication in Spanish or English.
- Not pregnant
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Science of Education Faculty Coordinator of this site? Confirm its status | Puerto Real | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.