Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of Red Wine Polyphenols on Microvascular Dysfunction
Brief Summary: Rationale:

Epidemiological studies have shown that consumption of alcoholic beverages, red wine in particular, is associated with less cardiovascular mortality. In addition, there are reported beneficial effects of red wine on components of the metabolic syndrome, arguably the most menacing cardiometabolic condition facing us due to the unfolding obesity epidemic. Beneficial effects have also been reported with other polyphenol-rich food stuff, such as cocoa and green tea and points to a beneficial effect which does not seem to be dependent on the alcohol content of red wine. Experimental studies with mixed or separate Red Wine Polyphenols (RWPs) (i.e. without alcohol) have shown beneficial effects on cardiometabolic parameters associated with obesity. Most research has focused on resveratrol, a specific polyphenol components which is quite specific to red wine and has, at least in animal studies, beneficial effects on insulin sensitivity, insulin secretion, and endothelial function. Moreover, RWPs have shown to improve endothelial NO-mediated relaxation using the same PI3-kinase/Akt pathway as does insulin. However, data in humans are remarkably scarce

Objective:

To study effects of RWPs on insulin sensitivity, beta-cell function, microvascular function (skin, muscle and cardiac), blood pressure, insulin-mediated microvascular responsiveness.

Study design:

Randomized controlled trial (double blind).

Study population:

Obese (BMI \>30); n=30, men or women, aged 18-60 years.

Intervention:

Mixed RWP 600mg/day or matching placebo for a total duration of 8 weeks.


Options:
A: Inclusion Criteria:

* Caucasian
* age 18-60 years
* obese (BMI \>30)

Exclusion Criteria:

* cardiovascular disease
* smoking
* diabetes mellitus
* recent history (\<12 months) of high alcohol use \> 4 U/day
* use of medication potentially affection insulin sensitivity or microvascular function
* pregnancy
B: Inclusion Criteria:

1. Age between 40-75 yrs.
2. Alcohol abstainers (less than or equal to 1 drink/week)
3. Established diagnosis of type 2 diabetes.
4. Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.

Exclusion Criteria:

1. Taking Insulin \>2 injections /day, or with insulin pump.
2. TGs\>500 mg/dL.
3. HbA1c \>10%
4. Serum creatinine \> 2 mg/dl
5. Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)

5. Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).

6. Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness. 7. Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert. 8. Presence of active cancer, receiving or had received chemotherapy in last 3 years.

9. Suffering a major illness that might probably require hospitalization (upon physician's evaluation).

10. Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.

11. Severe symptoms during run-in as assessed by the physician. 12. Pregnant or lactating women. 13. Participation in another trial in which active intervention is being received.

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C: Inclusion Criteria:

* Diabetes
* Current Smoking
* Hypertension
* Family history of heart disease
* High LDL Cholesterol (\>130 mg/dl)
* Low HDL CHolesterol (\<40 mg/dl)
* Body Mass Index of 30 kg/m\^2
* Waist circumference greater than 40 inches for men and 35 inches for women
* Report intake of at least one drink in the last month
* Post-menopause (if woman)

Exclusion Criteria:

* History of myocardial infarction (MI)/ heart attack within prior 6 months.
* Revascularization procedure (coronary, carotid, or peripheral)
* Stroke
* Claustrophobia
* Intolerance to previous MRI examinations
* Standard MRI contraindications (e.g. pacemaker, intra-auricular implants, or intracranial clips)
* Weight over 350 pounds
* Active atrial fibrillation
* Reports intake of more than 7 drinks per week currently, has previous or current history of alcohol abuse based on standard questionnaires, or who has consumed more than 4 drinks in one day within the last 6 months.
* Intolerance or allergy to alcohol consumption (includes flushing)
* Allergy to aspartame, acesulfame, or artificial food coloring
* Any severe illness expected to cause death or profound disability within 6 months
* Evidence of depression (as measured based on a Center for Epidemiological Studies Depression score of 16 or higher)
* History of chronic liver disease
* Personal history of breast or any gastrointestinal cancer, uncontrolled hypertension (blood pressure greater than or equal to 180/110)
* Chronic renal failure on dialysis
* Current use of Metronidazole or Warfarin
* Use of benzodiazepines, barbiturates, and related sedative/ hypnotics 4 or more days per week.
* Severe psychiatric illness
* Inability to speak English
* Lack of a working telephone
D: Inclusion Criteria:

* Established diagnosis of type 2 diabetes
* Male or female alcohol abstainers (not more than 1 drink/week)
* Age between 40-75 yrs
* Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months

Exclusion Criteria:

* The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion
* Triglycerides \> 500 mg/dL
* HbA1c\<7 or \> 10%
* Serum creatinine \> 2 mg/dl
* Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST)
* Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy)
* Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness
* Patients with chronic hepatitis (C,B)
* Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants
* Presence of active cancer, or chemotherapy within the past 3 years
* Major illness that may require hospitalization
* A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse
* Pregnant or lactating woman
* Participation in another trial with active intervention

Answer: A