Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
Brief Summary: The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory, anti-thrombotic, and anti-oxidative atherosclerotic protection when administered at the optimal dose as determined by surrogate markers of inflammation, hypercoagulability, and oxidation.


Options:
A: DISEASE CHARACTERISTICS:

* Healthy male volunteers
* Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry

  * Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
* Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
* No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* Systolic blood pressure \< 160 mm Hg
* Diastolic blood pressure \< 90 mm Hg
* No history of hemorrhagic stroke

Other:

* No malignancies within the past 5 years except basal cell or squamous cell skin cancer
* No uncontrolled medical illness
* No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
* No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
* Concurrent multivitamins allowed (supplied on study)
* No concurrent anticoagulation therapy (e.g., warfarin)
* Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed

  * Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
* Concurrent anti-hypertension medication allowed
* No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)
B: Inclusion Criteria:

* 60 years of age and older
* English speaking
* Not living in a skilled or intermediate care level nursing facility
* No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
* A Mini-Mental State Exam (MMSE) score ≥ 23

Exclusion Criteria:

* A cognitive deficit greater than that indicated according to the MMSE score
* A clinical diagnosis of AD and/or related disorders
* A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
* Bleeding disorders
* Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
* Gastrointestinal disorders causing impaired absorption of the study supplements
* Insulin-dependent diabetes
* Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure
* Hematologic or oncologic disorders treated with chemotherapy in the previous two years
* Active chemotherapy or radiation treatment for cancer
* Current cigarette smoking
* More than three major medical or psychiatric hospitalizations in the past year
* Diagnosis of a terminal illness
* A T score \> 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
* A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)
* Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit
* Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine
* Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants
* Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial
* Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function
C: Inclusion Criteria:

* women aged 35-60 years, men aged 45-60 years
* acceptance of the possibility to be given a placebo and acceptance of the constraints of participation
* lack of previous regular supplementation with any of the vitamins or minerals in the supplement provided
* absence of extreme beliefs or behavior regarding diet

Exclusion Criteria:

* disease likely to hinder active participation or threatened 5-year survival
D: Inclusion Criteria:

* The study will enroll subjects, both men and women with type 2 diabetes of at least six months duration. The age of enrolled subjects will range from 21-60 years old. An HbA1c blood test must show that the person's diabetes is under control. Eligible subjects must have normal electrocardiogram tracings and normal hematological, electrolyte and liver laboratory results at screening. Females of childbearing age must agree to use an effective form of birth control throughout the study period.

Exclusion Criteria:

* Subjects will be excluded if they have known vascular disease, uncontrolled hypertension (\>140/90 mmHg), marked hyperlipidemia (serum low density lipoprotein \> 4.1 mmol/L or serum triglycerides \> 7.8 mmol/L), and a body mass index greater than 40 kg/m2 (range 27-40). Other important exclusion criteria are cigarette smoking, volunteers taking Coumadin, and recent use of antioxidant supplements or aspirin. Females who are pregnant or breastfeeding will be excluded. People cannot participate in this study if they are taking medications (other than antidiabetic medications) which may affect blood sugar.

Answer: D