Status:
COMPLETED
Dietary Intervention Modifies Gut Microbiota in Type 2 Diabetes.
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborating Sponsors:
University of Connecticut
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
Aim: To study the effect of a dietary intervention with functional foods on gut microbiota in subjects with type 2 diabetes Materials and methods: Patients with type 2 diabetes were enrolled in a doub...
Detailed Description
This study was a single-center, randomized, controlled, double-blind, parallel versus placebo that consisted of six visits. The first visit was a screening evaluation to determine whether subjects mee...
Eligibility Criteria
Inclusion
- clinical diagnosis of type 2 diabetes
- Male or female.
- Adults between 30 and 60 years old.
- BMI of 25 to 39.9 kg / m².
- Pharmacological treatment with metformin, a combination of metformin and glibenclamide.
- Evolution of the type 2 diabetes of 4 ± 3 years.
- Patients who knew how to read and write.
- Signature of informed consent.
Exclusion
- Diseases that produce secondary obesity.
- Cardiovascular event.
- Weight loss\> 3 kg in the last 3 months after the evaluation of the criteria.
- Catabolic diseases such as cancer and acquired immunodeficiency syndrome.
- Gravidity status.
- Positive smoking.
- Treatment with antihypertensive drugs
- Treatment with other hypoglycemic agents that were not metformin
- Treatment with statins, fibrates or other drugs to control dyslipidemia, 6 months before the start of the protocol.
- Any drug or medication that activates intestinal motility
- Use of laxatives or antispasmodics 4 weeks before the study
- Treatment with antibiotics 6 months before the study
- Use of steroids, chemotherapy, immunosuppressant or radiotherapy.
- Uncontrolled type 2 diabetes, ( HbA1c concentration ≥ 9.9%)
- Fasting glucose ≥ 220 mg / dL
- Fasting cholesterol ≥ 240 mg / dL
- Fasting triglycerides ≥ 350 mg / dL
- Serum creatinine in women\> 1.2 mg / dL in men\> 1.3 mg / d
Key Trial Info
Start Date :
August 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2016
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03421301
Start Date
August 7 2014
End Date
December 28 2016
Last Update
February 5 2018
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