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Physical Exercise, Diet, and Health in People With Type 2 Diabetes: Longitudinal Design of the EDUGUTION Study

NCT06219850 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-01-23

No results posted yet for this study

Summary

This longitudinal design study is a continuation of the EDUGUTION project (Ref: PID2019-110063RA-I00; Clinical Trial: NCT05261373), a randomized controlled trial that was approved by the Clinical Research Ethics Committee of Cadiz (Registration No. 92.21; PEIBA No. 1026-N-21) in 2021. The aim of this study was to determine the benefits of three months of intervention with physical exercise and nutritional counseling on health in patients with type 2 diabetes.

Specifically, the aim of the present longitudinal study is to analyze the possible changes that may have occurred in the health and lifestyle habits of the subjects of the EDUGUTION project one year after the end of the study. The tests to be performed are the following: 1) Analysis of sociodemographic information, diet and habits and quality of life with previously validated questionnaires, 2) Fasting blood collection, 3) Anthropometric and body composition assessment, 4) Assessment of physical fitness: manual grip strength and maximal oxygen uptake test.

On the same day in the morning, participants will have to go to the University Hospital of Puerto Real and to the Exercise Physiology Laboratory of the Faculty of Education Sciences of the Puerto Real Campus of the University of Cadiz, one year after the end of the EDUGUTION study. Since there is no intervention, the duration of the study is a single day. In this study 120 patients will participate, the same patients who were included based on the inclusion and exclusion criteria and who completed the EDUGUTION study intervention one year earlier.

Conditions

Interventions

OTHER

No intervention

The study sample is divided into the six intervention groups of the EDUGUTION study (ClinicalTrials.gov Identifier: NCT05261373), although participants do not receive intervention in the present study, as only a description of the sample is made one year after the EDUGUTION study from a longitudinal perspective.

Sponsors & Collaborators

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • University of Cadiz

    lead OTHER

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-08-01
Completion
2025-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219850 on ClinicalTrials.gov