Status:
COMPLETED
Vitamin E Pharmacokinetics and Biomarkers in Normal and Obese Women
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes
Fatty Liver
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
Background: * Vitamin E is an antioxidant that reduces the damaging effects of oxygen in the body. Most American men (90%) and women (96%) do not get enough vitamin E from their diets; however, the a...
Detailed Description
Vitamin E (alpha-tocopherol) is essential for humans but determining human dietary requirements has proved difficult. The recommended dietary allowance (RDA) for vitamin E is not met by 96% of America...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects to be recruited for the study:
- Healthy women
- Ages 18 to 40 years old
- Able to give informed consent
- Blood pressure \<160/90 mm Hg
- Nonobese (BMI less than or equal to 29.9) without diabetes
- Overweight (BMI greater than or equal to 27) without diabetes
- Overweight (BMI greater than or equal to 27) with mild to moderate non-insulin dependent diabetes (Type 2 diabetes)
- who are treated with diet alone or submaximal doses of oral hypoglycemic agents
- whose fasting blood sugar is \< 200mg/dl or HbA1C \< 7.5
- with no known target organ damage (End organ damage includes the following: proliferative retinopathy, serum creatinine \< 1.8 m/dl, ischemic heart disease, congestive heart failure, peripheral vascular disease and peripheral neuropathy)
- No regular medication other than aspirin (other than oral hypoglycemic agents, hormonal contraceptives and medications taken only on an as-needed basis).
- Willingness to use effective contraceptive methods for the duration of the study
- EXCLUSION CRITERIA:
- Subjects with the following diseases or abnormalities will not be eligible for the study:
- Digestive abnormalities, such as malabsorption or chronic diarrhea
- Organ malfunction, including (but not limited to) liver disease, pulmonary disease, ischemic heart disease, heart failure, stroke, peripheral vascular disease
- Hypertension (blood pressure \>160/90)
- Anemia (hematocrit \< 30)
- Current or history of serious or chronic illness, including hyperlipidemia or hypercholesterolemia
- Complications from diabetes such as kidney damage (renal insufficiency, serum creatinine \>1.8), eye damage (proliferative retinopathy), diabetic neuropathy, coronary artery disease, or peripheral vascular disease
- Tobacco smoking
- Use of medications (other than oral hypoglycemic agents, hormonal contraceptives and medications taken only on an as-needed basis).
- Alcohol or drug abuse
- Insulin treatment
- Pregnancy or lactation (a urine pregnancy test will be performed on all women with reproductive age before each part of the study or monthly as necessary)
- Positive HIV or hepatitis (b or c) screening tests
- Food allergy, to soy or egg, milk protein (casein), or wheat/gluten
- Known coagulopathy
- Unwillingness to use effective contraceptive methods such as barrier methods for the duration of the study.
- Patients on antihypertensive medication are excluded even if blood pressure is well controlled because antihypertensive medication may affect vitamin E status, thus introducing a confounding variable. Whether antihypertensive medication interacts with vitamin E is not
- known. Patients on insulin treatment are excluded because Insulin treatment indicates a more severe form of diabetes than the mild to moderate type two diabetes that need only dietary treatment or treatment with submaximal doses of oral hypoglycemic agents for adequate blood sugar control. The effect of insulin administration on vitamin E is unknown, and is a confounding factor that will make data interpretation difficult.
Exclusion
Key Trial Info
Start Date :
October 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00862433
Start Date
October 10 2014
End Date
May 3 2022
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892