Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

University of Cadiz

Collaborating Sponsors:

Ministerio de Ciencia e Innovación, Spain

Conditions:

Fat Burn

Diabetes Mellitus, Type 2

Eligibility:

All Genders

40-55 years

Brief 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 Rese...

Detailed Description

1. Sociodemographic Information and Questionnaires Sociodemographic information will include gender, age, ethnicity, education, employment and position in the organizational hierarchy, household c...

Eligibility Criteria

Inclusion

  • Non smoking
  • Non-alcoholic (\<3 standard drinks per day)
  • Body mass index \>25 kg/m maintaining the habitual dietary patterns without a body mass reduction higher than 2% during the last 6 months
  • Not being insulin dependent
  • Absence of injury, disease or disability or other known medical condition which could affect the ability to successfully participate in physical exercise tests
  • Absence of cardiovascular disease (angina, peripheral or cerebro-vascular disease).
  • Absence of neurologic and psychiatric diseases.
  • Absence of respiratory diseases (pulmonary hypertension, Chronic obstructive pulmonary disease, etc.).
  • Absence of other metabolic diseases (hyper/hypo parathyroidism, hyper/hypothyroidism, Cushing's disease, Type 1 diabetes, etc.)
  • Absence of active inflammatory bowel disease
  • Absence of kidney disease
  • Absence of tumours
  • Absence of coagulation dysfunction
  • Not under treatment with medications k known to affect glucose metabolism, recent steroid treatment (within 6 months), or hormone replacement therapy
  • Be able to understand a communication in Spanish or English.

Exclusion

  • Failure to complete the EDUGUTION study measurements and the intervention.

Key Trial Info

Start Date :

February 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2025

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06219850

Start Date

February 1 2024

End Date

January 1 2025

Last Update

January 23 2024

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