Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double Blind, Randomized, Placebo Controlled Study to Determine the Physiological Effectiveness of Januvia for Reducing Inflammation and Increasing EPC Number in HIV Infected Men and Women With Insulin Resistance and Central Adiposity.
Brief Summary: People living with human immunodeficiency virus infection (HIV) have 2-4fold greater risk for developing diabetes and heart disease than the general population. They need safe and effective treatments that reduce the risk for developing diabetes and heart disease, and improve their quality of life. This project will explore whether a new anti-diabetes medication (Januvia) with a novel mechanism of action reduces inflammation, and improves blood vessel function in HIV infected men and women with several risk factors for developing cardiovascular disease.


Options:
A: Inclusion Criteria:

1. Males age 18-65 years old
2. Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
3. 2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
4. Patients must have BMI of 25-40 kg/m2
5. Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.
6. Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.
7. Patients must have the following laboratory values:

   * Hematocrit ≥ 34 vol%
   * Serum creatinine\* ≤ 1.5 mg/dl in males and
   * Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
   * Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal
   * Alkaline phosphatase ≤ 2.5 times upper limit of normal
   * If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is \>70 ml/min

Exclusion Criteria:

Patients are excluded from participation in the study if they meet any of the following criteria:

1. Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
2. Patients with BMI over 40 and under 25
3. Patient with age below 18 yrs and over 65 yrs
4. Female subjects
5. Patients with type 1 diabetes
6. Patients treated for type 2 diabetes
7. Subjects with normal glucose tolerance (NGT)
B: Inclusion Criteria:

* 18-65 yr old HIV infected men and women.
* Stable (at least the past 6 months) on combined antiretroviral therapy (cART).
* Stable immune (\> 300 CD4+ T-cells/µL) and virologic (\< 50 copies HIV RNA/mL) status.
* Insulin resistant/impaired glucose tolerance (fasting glucose 100-125mg/dL, or 2-hr glucose 140-200mg/dL or fasting HOMA-IR= 2.5-6.0).
* Waist circumference \> 102 cm (men), \> 88 cm (women).
* BMI \> 20 kg/m2.
* Fasting hypertriglyceridemia \> 150 mg/dL.
* Low HDL-cholesterol (\< 40 mg/dL in men or \< 50 mg/dL in women).
* Platelet count \> 30,000/mm3.
* Absolute neutrophil count \> 750/mm3.
* Transaminases \< 2.5x the upper limit of normal.
* Long-term non-progressors (not taking anti-HIV medications) are not eligible.

Exclusion Criteria:

* Diabetes (T2DM, IDDM or diabetic ketoacidosis) or taking any glucose-lowering medication (e.g., insulin, TZDs, metformin, sulfonylurea).
* Any agent that might artifactually alter glycemic control (e.g., glucocorticoids, megace, rhGH, GH-secretagogue, testosterone derivatives, creatine monohydrate, chromium picolinate, AA/protein supplements, medium- or long-chain fatty acids) during 6 months prior to or during enrollment.
* History of serious CV disease. NYHA Functional Class III or IV (e.g., recent MI, unstable angina, edema, CHF, CAD, CABG, stroke, resting hypertension \> 160/95 mmHg), irregular heart rhythm, resting ST-segment depression \> 1mm). Treatment with medications for CV condition (e.g., α- or ß-blockers). Some BP-lowering medications (Ca++channel blocker, diuretic, or ACE inhibitor) are permitted.
* Moderate to severe renal insufficiency. Serum creatinine \> 1.7 mg/dL (men) \> 1.5 mg/dL (women).
* Plan or anticipate a change in anti-HIV medications during the study.
* Lipid-lowering medications are permitted (fibrate or statin or niacin), but must be stable on that agent for at least 6 months prior to enrollment. Lipid-lowering agents cannot be started during the treatment period.
* Chronic hepatitis B (HBV-surface antigen positive). Active hepatitis C (detectable Hep C RNA).
* Positive urine drug test for opiates, methamphetamine, heroin, cocaine. Active substance abuse that the MD-scientist believes may compromise safety, compliance, interfere with study drug or data interpretation.
* Hematocrit \< 34% in men or \< 25% in women with symptoms (fatigue, "tired-legs", shortness of breath). Hemoglobin \< 10 gm/dL with symptoms.
* Pregnant or nursing mothers. Women must agree to use an acceptable form of birth control during the study. If using birth control pills-must be stable on this medication for at least 6 months prior to enrollment.
* Active malignancy or treatment with chemotherapeutic agents or radiation therapy or any cytokine or anti-cytokine therapy during 6 months prior to enrollment.
* History of pancreatitis
* \> 10% unintentional weight loss during the 6 months prior to enrollment.
* Reduced cognitive function/unable to provide voluntary informed consent. Prisoners are excluded.
* Blinded investigational drugs for 3 months prior to enrollment that will not be unblinded before enrollment.
* Nausea, vomiting, diarrhea (\> 4 loose stools/day) that are unresponsive to treatment.
C: Inclusion Criteria:

* Body Mass Index (BMI) of either 30 kg/m\^2 or more or BMI of less than 30 kg/m\^2 to 27 kg/m\^2 with presence of co-morbidities
* Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
* Previously undergone dietary weight loss and was not able to maintain reduced weight

Exclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes
* Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
* Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
* Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
* Current participation in an organized diet reduction program (or within the last 3 months)
* Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
* Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
* History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
* Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
D: Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
* High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Exclusion Criteria:

* Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
* Acute vascular event \<2months prior to randomisation

Answer: B