Please select the eligibility criteria that correspond to the clinical trial below.
Title: Strategies for the Treatment of HIV Associated Metabolic Syndrome
Brief Summary: A healthy diet and exercise have improved the health of people without human immunodeficiency virus (HIV) who have Metabolic Syndrome. In this study we would like to find out if the same benefit can be seen in people with HIV and Metabolic Syndrome. Patients with Metabolic Syndrome usually have a large waist, high blood cholesterol levels, high blood pressure, and high blood sugar levels. These are risk factors, which may increase one's chance of developing heart disease and/or diabetes. The purpose of the study is to evaluate the effects of different methods of treating HIV associated Metabolic Syndrome. The groups are: 1) a lifestyle modification program plus metformin (also known as glucophage), 2) lifestyle modification plus placebo, 3) metformin alone or 4) placebo alone. The lifestyle modification program consists of nutrition and exercise sessions with the goal of improving body composition, heart health, and ways to lower the risk of developing diabetes.


Options:
A: Inclusion Criteria:

* age 18-70 years
* body mass index \> 27 kg/m2

Exclusion Criteria:

* history of cardiovascular symptomatology
* cholelithiasis
* urolithiasis
* insulin dependent diabetes
* pacemaker implantation
* pregnancy
* lactation
* vegetarianism
B: Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years of age
* HIV positive, on a stable combination antiretroviral regimen for \> 6 months, including but not limited to either 2 nucleoside reverse transcriptase inhibitors (NRTI) and a non-nucleoside reverse transcriptase inhibitors (NNRTI) or protease inhibitor (PI), or a triple NRTI regimen
* Ability and motivation to modify behavior and make lifestyle changes
* NCEP-Adult Treatment Panel III defined metabolic syndrome, as defined by 3 out of 5 of the following: 1) Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women, 2) Triglycerides ≥ 150 mg/dL or current anti-lipolytic drug treatment, 3) high-density lipoprotein less than 40mg/dL in men and 50 mg/dL in women, 4) Blood pressure ≥ 130/85 mmHg or current antihypertensive drug treatment, 5) Fasting glucose ≥ 100 mg/dL

Exclusion Criteria:

* Any new serious opportunistic infection within the past 6 weeks
* History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
* Current therapy with insulin or other diabetic agent, fasting blood sugar \> 126
* Requiring parenteral nutrition or parenteral glucocorticoid therapy or oral glucocorticoid therapy
* Estrogen, progestational derivative, or ketoconazole use within 3 months
* New antiretroviral regimen in the past 6 months
* Serum creatinine \> 1.5 mg/dL (males) and 1.4 mg/dL (females), serum glutamic pyruvic transaminase-liver function (SGPT), \> 2.5 upper limit of normal (ULN), Lactate \> 2.0 ULN, hemoglobin \< 10.0 mg/dL
* Current substance and/or alcohol abuse
* Known hypersensitivity to Metformin
* Congestive heart failure requiring pharmacologic treatment
* Use of cimetidine or planned use during the study period
* Hypertrophic obstructive cardiomyopathy
* Pregnant or actively seeking pregnancy, breastfeeding
* Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for \< 3 months.
* Presence of active AIDS including cancers
* Current viral, bacterial or other infections (excluding HIV)
* Weight loss in the past 3 months of greater than 10 pounds
* Nitrates or other medications that can alter endothelial function
* Contraindication to beta blocker or nitroglycerin use
* Patients with previous allergic reactions to iodine-containing contrast media or to iodine
C: Inclusion Criteria:

1. Age 18 years or older;
2. Body mass between 30 and 55 kg/m2
3. One or more CHD risk factors: Systolic blood pressure between 130 and 200 mmHg; Diastolic blood pressure between 80 and 105 mmHg; Total cholesterol \> 180 mg/dL; LDL cholesterol \> 120 mg/dL; HDL Cholesterol \< 40 mg/dL; Triglycerides \> 150 mg/dL; HbA1c between 6.0 and 11.5%; Fasting plasma glucose between 95 and 400 mg/dL; Diagnosis of Type 2 diabetes
4. Residing in catchment area of the Fair Oaks Adult Clinic and receiving primary care at Fair Oaks Adult Clinic.

Exclusion Criteria:

1. Inability to speak Spanish;
2. Unwilling to attempt weight loss;
3. Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, advanced heart failure, and ongoing substance abuse;
4. On greater than 10 prescription medications;
5. Psychiatric disorders requiring antipsychotics or multiple medications;
6. Body weight change \> 25 lbs. in the preceding 3 months;
7. Pregnant, planning to become pregnant, or lactating less than six months;
8. Family household member already enrolled in the study;
9. Intends to or is enrolled in a study that would limit full participation in VAFO;
10. Participants who are unwilling to have home visits by study staff;
11. Resident of a long term care facility;
12. Plans to move during the study period (24 months post-randomization);
13. Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
D: Inclusion Criteria:

* Age ≥ 21 years

  * BMI 30-50 kg/m2 and weight ≤ 400 lbs.
  * At least 2 of 5 criteria for metabolic syndrome

    * Elevated waist circumference (\> 102 cm for men, \> 88 cm for women)
    * Elevated blood pressure (≥ 130/85 mmHg)
    * Impaired fasting glucose (≥ 100 mg/dl)
    * Elevated triglycerides (≥ 150 mg/dl)
    * Low HDL cholesterol (\< 40 for men, \< 50 mg/dl for women)
  * Willing to change diet, physical activity and weight
  * Willing to accept randomization to each group
  * Able to give informed consent
  * Patient of participating PCP

Persons with the following conditions are eligible with PCP approval:

* Diabetes mellitus
* Prior CVD event \> 6 months before randomization
* Stable CVD or peripheral vascular disease

Exclusion Criteria:

* Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment within 2 yrs)
* Prior or planned bariatric surgery
* Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine)
* Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight)
* Intentional weight loss within 6 months of enrollment (≥ 5% of body weight)
* Pregnant or nursing within past 6 months
* Plans to relocate from the area within 2 years
* Another member of household is a study participant or staff in the trial
* Consumes \> 14 alcoholic drinks per week
* Current use of illicit substances
* Psychiatric hospitalization in last year
* Psychiatric condition likely to impair adherence to treatment (e.g., schizophrenia)
* Blood pressure ≥ 160/100 mmHg; patient may be re-screened in 1 month
* Principal Investigator or PCP discretion

Answer: B