Status:
COMPLETED
Post-prandial Effects of Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes
Lead Sponsor:
Griffin Hospital
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
Purpose: The number of cases of adults with Type 2 diabetes has quadrupled since 1980. This increase in the number of cases of diabetes is attributed to changes in dietary patterns, which include an ...
Detailed Description
Diabetes is a public health problem of epidemic proportions. According to the 2017 National Diabetes Statistics Report, 30 million people, or 9.4% of the U.S. population, are estimated to have diabete...
Eligibility Criteria
Inclusion
- Male and female age 25-75 years;
- non-smokers;
- post-menopausal females not currently on hormone replacement therapy;
- at risk for Type 2 diabetes as defined by meeting at least one of the criteria listed below: (a) metabolic syndrome, i.e. meet 3 out of 5 of the following criteria: (i) blood pressure \>130/85 mmHg or currently taking antihypertensive medication; (ii) fasting plasma glucose (FPG) \>100 mg/dL (6.1 mmol/L); (iii) serum triglycerides level (TG)\>150 mg/dL (1.69 mmol/L); (iv) high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1.04 mmol/L) in men, and \< 50 mg/dL (1.29 mmol/L) in women; (v) overweight (body mass index, or BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women; (b) fasting blood glucose \>100mg/dL and \<126mg/dL or hemoglobin A1C 5.7-6.4 %.
Exclusion
- failure to meet inclusion criteria;
- anticipated inability to complete study protocol for any reason;
- current eating disorder;
- use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
- regular use of fiber supplements;
- diabetes;
- sleep apnea;
- restricted diets by choice (e.g., vegetarian, vegan);
- coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage, or current use of warfarin;
- regular exercise as defined by participating in moderate-intensity \> 150 minutes/week.
Key Trial Info
Start Date :
July 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04025281
Start Date
July 9 2019
End Date
August 22 2019
Last Update
March 30 2020
Active Locations (1)
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1
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418