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NCT05261373: EDUGUTION
Efficacy of a Nutritional Education Strategy and Physical Exercise on the Gut Microbiota in Type 2 Diabetics
NA trial testing The Moderate-Intensity Continuous Training (MICT) in Diabetes Mellitus, Type 2 in 120 participants. Status unknown.
1 September 2023
Quick facts
| Lead sponsor | University of Cadiz |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 10 March 2022 |
| Primary completion | 1 September 2023 |
| Estimated completion | 31 August 2024 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- The Moderate-Intensity Continuous Training (MICT)
- The High-Intensity Interval Training (HIIT)
- Behavioral: Nutritional education program
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
- Fat Burn — all drugs for Fat Burn →
- Metabolism Disorder — all drugs for Metabolism Disorder →
Sponsor
University of Cadiz
Who can join
Adults 40 to 55, any sex, with Diabetes Mellitus, Type 2 or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
We hypothesize that the combination of a nutritional education intervention with a HIIT-based physical exercise program improve muscle metabolism through positive modifications of gut microbiota in people with T2DM, leading to better glycaemia/insulinaemia levels, reduction of body fat mass and improving quality of life. The project is a randomized controlled clinical trial in 120 participants with T2DM and obesity, which aims to determine the efficacy of a nutritional education program and the role of physical exercise type on health related variables. The participants will be of both sexes with age between 40 and 55 years, belonging to the Province of Cádiz. The design has two 12-week interventions; the main factor has 2 levels: participants who receive the nutritional education (EDU) and controls (CG); the second factor has 3 levels: high-intensity interval training (HIIT), moderate intensity continuous training (MICT), and controls (INACT). Therefore, participants will be randomized into 6 groups (n=20), adjusted by gender (≈50% in each group): EDU+HIIT, EDU+MICT, EDU+INACT, CG+HIIT, CG+MICT, CG+INACT. The outcome variables, which will be measured before and after the intervention, will include: dietary intake assessment, physical activity assessment, quality of life, faecal samples, blood samples, blood pressure, appetite assessment, muscle biopsy samples, body composition and fluids, basal metabolism, maximal fat oxidation test and cardiorespiratory fitness.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05261373
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
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- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
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Other University of Cadiz trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05261373 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cadiz
- Last refreshed: 3 November 2022
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