Status:
UNKNOWN
Effect of MEDiterranean Diet on the microBIOME of Individuals With Type 2 Diabetes
Lead Sponsor:
Universidade Nova de Lisboa
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Dysbiosis of gut microbiota is associated with the pathophysiology of type 2 diabetes. Mediterranean diet has been indicated as a dietary pattern that promote the integrity of gut barrier and that has...
Eligibility Criteria
Inclusion
- Men and women diagnosed with type 2 diabetes mellitus, according to the American Diabetes Association criteria;
- Ages 40-80 years;
- Non-smoker;
- Willing and able to provide written informed consent.
Exclusion
- Diabetes diagnosed before 40 years old;
- Changes in oral glycaemic-control medications in the last 3 months;
- Subjects with HbA1c levels under 6.4% or above 10%;
- Subjects under insulinotherapy;
- Subjects under corticotherapy;
- Subjects with triglycerides levels above 4.52 nmol/L (400 mg/dL);
- Intake of antibiotics in the last 12 weeks;
- Subjects with a diagnosis of any digestive disease including functional bowel disorders such as IBS.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04403217
Start Date
April 1 2019
End Date
September 30 2021
Last Update
May 27 2020
Active Locations (1)
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1
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon, Portugal, 1169-056