Status:
WITHDRAWN
Effect of EGCG on the Body's Response to Insulin
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Hypertension
Obesity
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief Summary
This study will examine whether epigallocatechin gallate (EGCG), a major component of green tea, affects how the body responds to insulin in healthy and obese people. Insulin is not as effective in pe...
Detailed Description
Green tea is a functional food whose consumption is associated with improved cardiovascular morbidity and mortality in several large epidemiological studies. One third of the solids in green tea are c...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- HEALTHY SUBJECTS:
- Men and women in good general health with no significant underlying illnesses who are between the ages of 21-65 years of age with HbA(1C) less than 6.5%, fasting blood glucose less than 100 mg/dL, blood pressure less than 120/80, and BMI between 20-25 kg/m(2). Subjects should have never smoked tobacco or not smoked within the previous year.
- OBESE SUBJECTS:
- Men and women in good general health with no significant underlying illnesses except obesity who are between the ages of 21-65 years of age with HbA(1C) less than 6.5%, fasting blood glucose less than 110 mg/dl, blood pressure less than 140/90, and BMI between 30-40 kg/m(2).
- EXCLUSION CRITERIA:
- ALL SUBJECTS:
- Subjects will be excluded from our study if they are pregnant , breastfeeding or if they plan pregnancy prior to the end of the study.
- In addition, subjects will be excluded if their age is greater than 65 yrs, BMI greater than or equal to 40 kg/m(2), or have liver disease (including liver transaminase levels greater than twice the upper limit of normal), pulmonary disease, renal insufficiency (serum creatinine greater than 2.0 mg/dl), coronary heart disease, heart failure (New York Heart Association heart failure Class III or IV), peripheral vascular disease, coagulopathy, major depressive disorder, actively smoking or used tobacco within the last year, history of cancer, in treatment for any form of cancer, positive tests for HIV, hepatitis B or C, or take systemic corticosteroids, thiazolidinediones (within 3 months), insulin, or anticoagulants, use food supplements that cannot be discontinued, regular intake of 8 or more cups of tea per week within 3 months prior to study entry, regular alcoholic beverage intake of more than two drinks per day (a drink corresponds to approximately 12 ounces of beer, 4 ounces of table wine, and between 1 and 1.5 ounces of 80-proof spirits), poor compliance during run-in period or regular use of medications that affect insulin sensitivity, blood pressure or vascular function and that cannot be discontinued.
- In addition, history of any other medical disease, laboratory abnormalities, or psychological conditions that would make the subject (based upon the principal investigator's judgment) unsuitable for study enrollment.
- Subjects with known hypersensitivity to octafluoropropane, recent eye surgery, or with known cardiac shunts will also be excluded from participating because of potential adverse effects from microbubble contrast agent.
- Subjects will be excluded if they are unable to give informed consent for all procedures.
- Currently, type 2 diabetes is not rare in children, however children are excluded from this study because children do not typically take EGCG and do not typically have hypertension or type 2 diabetes mellitus.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00434499
Start Date
February 1 2007
End Date
December 1 2015
Last Update
March 4 2022
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201