Status:
UNKNOWN
Efficacy of a Nutritional Education Strategy and Physical Exercise on the Gut Microbiota in Type 2 Diabetics
Lead Sponsor:
University of Cadiz
Collaborating Sponsors:
Ministerio de Ciencia e Innovación, Spain
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Eligibility:
All Genders
40-55 years
Phase:
NA
Brief Summary
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 pe...
Detailed Description
Approximately 500 million people have Type 2 Diabetes Mellitus (T2DM) in 2018 and it is expected to increase between 20% and 50% over the next 10 years. T2DM is also called non-insulin-dependent or ad...
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, etc.).
- 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
- They do not attend more than 2 or 4 consecutive sessions of nutritional counselling or physical training respectively.
- The lose more than 4 or 6 sessions in total of nutritional counselling or physical training respectively.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05261373
Start Date
March 10 2022
End Date
August 31 2024
Last Update
November 3 2022
Active Locations (1)
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1
Facultad de Ciencias de la Educación
Puerto Real, Cadiz, Spain, 11519