Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Exenatide on Postprandial Hyperlipidemia and Inflammation
Brief Summary: The primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. Secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.


Options:
A: Inclusion Criteria:

* Recently diagnosed type 2 diabetes (within 3 years) on diet or IGT
* Fasting triglyceride levels \>140 and \< 400 mg/dl and values varying less than 35% between two screening measurements
* Normal liver function tests and white blood cell count

Exclusion Criteria:

* Type 2 Diabetes for \> 3 years or HbA1c ≥ 7.5
* Known or suspected Type 1 Diabetes
* Any diabetes medications in the past 3 weeks, TZD in the prior 3 months or prior regular use of insulin
* Creatinine \> 2.0 mg/dl or other evidence of active kidney disease
* Hepatic enzyme elevation \> 2x normal
* Known Nonalcoholic Fatty Liver Disease
* Malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems
* Recent history of nausea or vomiting
* Acute bacterial or viral illness or evidence of other active infection in the past 4 weeks
* A prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months
* Current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (\>1 g/day)
* Any lipid lowering therapy in the prior 3 weeks other than a statin medication. Subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.
B: 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)
C: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
* Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.

Exclusion Criteria:

* Signs of type 1 diabetes mellitus
* Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
* Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
D: Inclusion Criteria:

1. Prior completion of at least two months in a diet, exercise and lifestyle intervention program within the past two years
2. Fasting plasma glucose \>90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1C ≤7.0%. There is no lower limit for the A1C and no upper limit for the OGTT 2-hour glucose based on prior studies that allow us to identify people with falling β-cell function
3. Age 22-65 years
4. Body mass index (BMI) 30-40 kg/m2
5. For participants with diabetes, known duration \<1 year
6. No history of use of antidiabetic medications except during pregnancy

Exclusion Criteria:

1. Contraindications to LapBand(see Appendix 1)
2. Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
3. Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
4. An underlying disease known to have important effects on glucose metabolism
5. Active infections
6. Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (\<3.4 or \>5.5 mmol/l)
7. Anemia (hemoglobin \<11g/dl in women, \<12 g/dl in men) or known coagulopathy
8. Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
9. Serum AST \>3 times upper limit of normal in local clinical lab
10. Excessive alcohol intake
11. Suboptimally treated thyroid disease
12. Conditions or behaviors likely to affect the conduct of the study

    1. unable or unwilling to give informed consent
    2. unable to adequately communicate with clinic staff
    3. another household member is a participant or staff member
    4. current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes
    5. likely to move away from participating clinic in next 2 years
    6. current (or anticipated) pregnancy and lactation.
    7. major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of the study
    8. weight loss \>5% in past three months for any reason except postpartum weight loss.
13. additional conditions may serve as criteria for exclusion at the discretion of the local site

Answer: A