Clinical Trial

Efficacy of Educational Nutrition and Exercise on the Regulation of Appetite Through Exosomes in Type 2 Diabetics

Study acronym: APETEX
Completed
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Summary
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 type 2 diabetes (T2D) and 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, and D-HIIT. Participants will: * Undergo a 12-week intervention within their assigned group. * Visit the research facilities three times per week if assigned to 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 NCT05259449
Lead Sponsor University of Cadiz
Collaborators: Ministerio de Ciencia e Innovación, Spain
Conditions Diabetes Mellitus, Type 2
Enrollment 146 participants
Start Date 2022-03-10
Primary Completion 2025-12-10 (estimated)
Study Completion 2025-12-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-28