Appetite Suppression / Hormone Study Control Group

The expected duration of participation in the study is up to 6 months before bariatric
surgery depending on participants' weight loss and insurance company requirements. A total of
10 patients will take part in this control group.

The following procedures and tests will be done before surgery: routine standard tests
required to be involved in the obesity surgery program (history and physical, blood work,
ECG, nutritional assessment, psychological assessment and sleep study). During preoperative
evaluation participants will be started on a medical weight loss diet with instructions
provided by the program's endocrinologist, nurse practitioners and dietitians with the weight
loss goals as stipulated by insurance companies and have a series of additional laboratory
tests (blood work) done to test the hormonal response to weight loss.

This blood work, which is drawn after eating a standardized meal, is the only experimental
procedure of the entire study. We will be measuring several hormones associated with obesity
including ghrelin, obestatin, peptide tyrosine tyrosine (PYY3-36), adiponectin, Glucagon-like
peptide-1 (GLP-1), oxyntomodulin, leptin, insulin, glucose and pancreatic polypeptide (PP).
Measurements will be done at 4 time intervals before surgery: at enrollment, +1-month,
+3-months, and +6-months. This will allow us to look at hormone levels as participants
gradually lose weight. If a participant reaches the insurance-dictated weight loss before 6
months, study participation will cease to allow the individual to proceed with surgery
scheduling.

Participants will be required to fast overnight prior to each visit. An intravenous line will
be placed at 0800, all subjects will be fed a standard breakfast (35% fat, 15% protein, and
50% carbohydrate) consisting of 25% of estimated caloric needs for weight maintenance, which
they will consume in 30 minutes or less. Blood will be taken beginning 30 minutes before the
standardized meal, then at time 0, then 30, 60, 90, and 120 minutes after the meal for total
ghrelin, pancreatic polypeptide, PYY3-36, active GLP-1, insulin, glucagon, leptin,
oxyntomodulin, and glucose. An extra fasting sample will be obtained for lipids and total
adiponectin. Three-quarters of a cup (148 mL) of blood will be drawn for analysis at each
visit. Additionally, subjects will be asked to complete a Visual Analog Scale (VAS) three
times during each research visit by placing a single vertical mark across a 100 mm in length
line, with words anchored at each end, expressing the most positive and the most negative
rating, to assess hunger, satiety, and fullness. Each visit will last approximately 4 hours.

Inclusion Criteria:

- Body mass index (BMI) of equal to or greater than 35 kg/m2, and less than 60 kg/m2

- Age great than or equal to 18 years and less than 70 years

- Able to provide informed consent

- If female with reproductive potential, agrees to use a reliable method of birth
control for the duration of the study (6 months)

Exclusion Criteria:

- Enrolled in another clinical study which involves an investigational drug

- Any condition where protocol compliance is unlikely (e.g. anxiety disorder, inadequate
comprehension)

- Pregnancy

- Previous gastric or esophageal surgery

- Immunosuppressive drugs including corticosteroids

- Type 2 diabetes

- Coagulopathy (INR > 1.5 or platelets < 100,00/ul)

- Anemia (Hgh < 10.0 g/dl)

- Any contraindication to treatment

- A severe concurrent illness likely to limit life (e.g. cancer)

- Significant malabsorptive or gastrointestinal disorder (e.g. pancreatic insufficiency,
Celiac sprue, or Crohn's disease)