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UNIVERSITY OF CALIFORNIA SAN FRANCISCO
GENERAL CLINICAL RESEARCH CENTER
CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Insulin Sensitivity after Gastric Bypass, Adjustable Gastric Banding
and Caloric Restriction in Persons with Morbid Obesity: A Stratified,
Randomized, Controlled Pilot Trial.

This is a medical research study. Your study doctor, Guilherme M Campos, MD, or one
of his associates will explain this study to you. Medical research studies include only
people who voluntarily choose to take part. Take your time to make your decision about
participation. You may discuss your decision with your family and friends and with your
health care team. If you have any questions, ask your study doctor.
You are being asked to take part in this study because you have qualified to undergo
either laparoscopic Roux-en-Y gastric bypass or laparoscopic adjustable gastric
banding at UCSF. Being in this study does not affect the type of surgical procedure you
will undergo.

Why is this study being done?
This study is designed to determine how gastric bypass or gastric banding surgery
affects diabetes and insulin resistance, which are very common problems in obese
individuals; and to see if the improvements in diabetes following surgery are better than
can be achieved by losing weight with diet alone.

How many people will take part in this study?
Thirty people will take part in this study over a period of about two years. Fifteen will be
people who choose gastric bypass surgery and the other fifteen will be people who
choose gastric banding surgery.

What will happen if I take part in this research study?
If you agree to participate and are eligible, the following will happen:
You will be ‘randomized’ to enter the “immediate surgery group” or the “diet group,”
which will subsequently undergo surgery. Randomization means that you are put into a
group by chance (like flipping a coin). Neither you nor your doctor can choose the group
(immediate surgery vs. diet followed by surgery) you will be in. You will have a 2:1
chance of being randomized to undergo immediate surgery. In other words, of 15
participants who are candidates for gastric bypass, 10 will undergo immediate gastric
bypass surgery and 5 will receive a diet followed by gastric bypass surgery. Likewise,
of the 15 participants who are candidates for banding, 10 will undergo immediate
banding surgery and 5 will receive a diet followed by banding surgery.
It is important to underscore that participating in the study does not speed up or delay
your surgery date and you will have the surgical procedure (either gastric bypass or
gastric banding) that you agreed upon with your surgeon. If you are randomized to the
diet group, your surgery (either gastric bypass or gastric banding) will be scheduled
independently of this study protocol and we will adjust the study tests to be performed
accordingly. Likewise, your group assignment does not affect the total number of tests
that will be performed.
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Regardless of which group your are assigned to, you will start the study by being
admitted to the General Clinical Research Center at the San Francisco General Hospital
(SFGH-GCRC) for about one and a half day to undergo a set of baseline tests that are
described below under the Section " What tests will be done?". The GCRC is a research
ward at SFGH. While you are in the GCRC, you will not be required to stay in bed the
whole time, and you will be allowed to leave the ward briefly if you want to go outside for
a walk. Certain tests will be performed each morning before you may eat, and on some
mornings you will have to remain in bed for several hours.
Immediate surgery groups (gastric bypass or gastric banding): After completing the
baseline set of tests, you will be discharged from the GCRC and admitted the next day
to the UCSF Moffitt-Long Hospital for your chosen operation. When you are considered
ready for discharge from the hospital (usually on post-operative day 1 or 2), you will be
discharged and you will be outpatient for 14-days. During these 14 days you will receive
a standardized commercial liquid diet regimen that consists of an 800 kcal/d. This liquid
diet is similar to that recommended to all persons after surgery. The diet will provide all
of your nutritional needs and is designed to have extra protein and vitamins that you will
need after surgery. Please note that the standardized diet regimen consists entirely of a
liquid diet, is portion-controlled, calorically precise, and has been shown to help people
stick to their diet plan. The benefits include high quality, complete nutrition, pre-
portioned and calorie-controlled servings, quick and simple preparation and enhanced
ability to stick with the diet because no food choices are made. You will be provided with
pre-packaged servings and instructed to follow a specific feeding schedule. You will be
asked to consume all of the diet that is provided to you, and you will not be allowed to
consume any other foods. You can drink as much plain water and noncarbonated diet
drinks as you need. Additionally, you will meet with the dietitian prior to the start of the
study for individual instructions regarding the diet and counseling on specific concerns
they might have. During the 14 day period, you will be asked to fill daily logs of all food,
water and drinks ingested, and you will be contacted every other day by the Bariatric
Clinical Research Fellow to provide continued guidance and medical monitoring of the
progress, health, and well-being throughout the course of treatment. Furthermore,
alternate-day phone calls from the research dietitian will allow the assessment of your
compliance. You will visit the GCRC on days 1 and 8 of the diet phase to be weighed on
the same scale, to receive the diet servings and review the diet diary forms.
Communication with the PI (Dr. Campos, Pager: 443-7353) or Co-I (Bariatric Clinical
Research Fellow, Pager: 443-8713) is provided 24 hours a day.
After those 14 days, all of the tests performed before your surgery will be repeated over
a one and a half-day period at the GCRC. During this one and a half day you will
continue to receive the same 800 kcal/d liquid diet provided by the nutritional service at
the GCRC. You will then be discharged to home to resume your normal activities. After
6 months you will be readmitted to the GCRC for about one and a half-day period to
take one final set of tests. You are then done with this study.
Diet Group: After the initial baseline evaluation (that is the same as described for the
persons randomly selected for the immediate surgery groups) you will be discharged
and you will be outpatient for 14-days and immediately start the standardized diet
regimen. This consists of an 800 kcal/d liquid diet. Please note that the standardized
diet regimen consists entirely of a liquid diet, is portion-controlled, calorically precise,
nutritionally complete, and has been shown to help people stick to their diet plan. The
benefits include high quality, complete nutrition, pre-portioned and calorie-controlled
servings, quick and simple preparation and enhanced ability to stick with the diet
because no food choices are made. You will be provided with pre-packaged servings
and instructed to follow a specific feeding schedule. You will be asked to consume all of
CHR APPROVAL # H49493-28734-01 EXPIRATION DATE: 08/22/2008 PAGE 2 OF 9
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the diet that is provided to you, and you will not be allowed to consume any other foods.
You can drink as much plain water and noncarbonated diet drinks as you need.
Additionally, you will meet with the dietitian prior to the start of the study for individual
instructions regarding the diet and counseling on specific concerns they might have.
During the 14 day period, you will be asked to fill daily logs of all food, water and drinks
ingested, and you will be contacted every other day by the Bariatric Clinical Research
Fellow to provide continued guidance and medical monitoring of the progress, health,
and well-being throughout the course of treatment. Furthermore, alternate-day phone
calls from the research dietitian will allow the assessment of your compliance. You will
visit the GCRC on days 1 and 8 of the diet phase to be weighed on the same scale, to
receive the diet servings and review the diet diary forms. Communication with the PI
(Dr. Campos, Pager: 443-7353) or Co-I (Bariatric Clinical Research Fellow, Pager: 443-
8713) is provided 24 hours a day.
Fourteen days after the diet period, you will again be admitted for about one and a half
day-period to the GCRC and will repeat all of the procedures outlined under Baseline
Evaluation (see above). After this one and a half day you will be admitted to the UCSF
Moffitt-Long Hospital for your chosen operation. After your surgery you will be
discharged to home from the hospital to resume your normal activities. After 6 months
you will be readmitted to the GCRC for about one and a half-day period to repeat all of
the tests done at baseline. You are then done with this study.

What tests will be done?
 Medical Chart Review and Physical Exam: Your medical chart will be
reviewed by the study doctors and you will have a routine physical examination
as part of your standard medical care.
 Weight: While you are in the GCRC your weight will be measured every
morning. This is being performed as part of this study for research purposes only.
 Baseline Blood Drawing (Venipuncture): You will be asked to give a blood
sample for a set of initial laboratory tests. Approximately 4 tablespoons of blood
will be drawn by inserting a needle into a vein in your arm. The specific tests to
be performed are the following: hormones (leptin, adiponectin), glucose, lipids
(triglycerides, LDL cholesterol), albumin and pre-albumin. In addition, small
samples of blood will be drawn several more times as you undergo the rest of the
tests. This is being performed as part of this study for research purposes only.
 Whole Body, Spine and Hip Dual-Energy X-ray Absorptiometry (DEXA): This
is a test to measure how much fat you have in your body and the density of your
bones. For this test, you will lie still on a padded table while a scanner passes
over your body. You will have three separate scans – of your whole body, hip
and spine. If you are a woman and capable of getting pregnant, you will have a
test to make sure you are not pregnant before each DEXA scan. This is being
performed as part of this study for research purposes only.
 Meal Challenge: In this test, we feed you a customized meal tailored with a
specific make-up of calories, fat, protein, and carbohydrates. We will draw a
series of 10 small blood samples (about 3 teaspoons each) at specific time points
before and after you eat your “challenge” meal. We will be tracking the pattern of
release of the following seven hormones that may affect your appetite or the way
your body handles the “challenge” meal: insulin, glucagon-like peptide-1, gastric
inhibitory polypeptide, cholecystokinin, Peptide YY, glucagon and ghrelin. This is
being performed as part of this study for research purposes only.
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 Indirect Calorimetry (Resting Energy Expenditure): This test measures the
number of calories you burn while you are resting. For this test, you will breathe
into a hood (canopy) that is hooked to a machine that pumps air through the
hood, while lying completely still for 30 minutes. This is being performed as part
of this study for research purposes only.
 Glucose/Insulin Infusion Study: This is a test to measure your body’s
sensitivity to the hormone insulin. We will infuse glucose and insulin for 2 hours
and collect blood samples periodically. Glucose is a sugar that your body uses as
fuel, and insulin is a hormone that helps your body process the glucose. A small
amount of your blood will be used to prepare the insulin infusion; this prevents
insulin from binding to the plastic syringe and tubing. Blood will be drawn every 5
minutes from a catheter in your arm, which will be placed in a warming pad, and
glucose will be infused to keep your blood glucose level constant. You will have
your resting energy expenditure measured again during this period. This is being
performed as part of this study for research purposes only.

Where will the study take place?
All study procedures will take place at the SFGH-GCRC (standardized diet, the
monitoring, and all the tests). When it is time for your surgery, you will be admitted to
Moffitt-Long Hospital on the UCSF Parnassus Avenue campus as a regular hospital
patient and get your surgery just like all our non-research patients.

What is a GCRC?
A nationwide network of General Clinical Research Centers (GCRC) specializes in
helping doctors conduct human research with complex protocols. These centers get
special funding from the National Institutes of Health and are exclusively associated
with university medical centers. Any given GCRC is usually just a designated hospital
ward and looks like any other. However, it functions independently with its own nursing
staff, patient care facilities, procedure rooms, testing facilities, and kitchen.

Can I have family or friends visit? Can they bring things for me?
You are welcome to have visitors during regular visiting hours. They are free to
socialize and bring you items of need. But they may not bring food, drink or snacks of
any kind. All visitors will need to check in with the nurses as they come and go. As
well, your visitors will need to fully cooperate with the nurses to make absolutely sure no
food or drinks are accidentally brought to you.

Can I leave the GCRC or visit with others?
The GCRC nurses will help you arrange for opportunities to leave the GCRC and get
fresh air. However, all outings must be supervised by GCRC staff. Your opportunities to
leave the GCRC may be decreased if available staffing is limited.

What is there to do at the GCRC?
There is a telephone available to make local calls. You should bring your own calling
card to make long-distance calls. Use of cellular telephones will be limited to only
specific areas according to hospital policy. You will have your own hospital style bed
but may be sharing your room and bathroom with other research study participants.
There is a common meeting room where you can visit with friends, family, staff or the
other study volunteers.
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Can I exercise?
The nurses can help you figure out ways to engage in light activity. However, we
cannot allow you to engage in extensive aerobic or strenuous exercise because doing
so may alter your metabolism in ways we cannot measure.

How long will the study take?
 If you are in the immediate surgery group, you will be with us for about 3 days the
first part of the study. In the first phase, there is about one and a half day for the
initial tests at the GCRC, 2-3 days to get your surgery, 2 weeks for the diet at
home, and then about one and a half day for the first follow-up set of tests at
GCRC. Then you come back after 6 months. This will be about one and a half
day stay to do the final set of tests at GCRC. Then you are done.
 If you are in the diet group, you will spend a similar amount of time with us. You
will start with the same one and a half day set of initial tests at GCRC, have the
diet for 2 weeks at home, and then spend the last one and a half day for the
follow-up set of tests at GCRC. Then 2-3 days to get your surgery and an
additional one and a half-day stay to do the final set of tests 6 months after the
surgery at GCRC. Then you are done.
 Can I stop being in the Study?
Yes, you can decide to stop being in the study at any time. Participating in this research
study is voluntary from beginning to end and your safety is our primary concern. If a
particular procedure makes you uncomfortable, or some minor problem comes up, we
will do our best to accommodate your needs. If absolutely needed, we will be happy to
release you from your study responsibilities. The study doctor may also release you
from participation if the study is ended early, you do not follow all the study rules, or he
believes it would be in your best interest. The participation in the study does not affect
the scheduling and performance of your proposed gastric bypass or gastric banding
surgery.

If I don’t participate or am released early from the study, do I still get my surgery?
At no time does your decision to participate in this study affect whether or not you get
your bypass or gastric banding operation. Everybody in our clinic is scheduled for
surgery in the same way and should expect the same waiting period.

What side effects or risks can I expect from being in the study?
Every experimental and testing procedure in this study has been safely performed on
humans in the past with most participants having experienced no ill effects. However,
you may have mild or serious side effects while in the study. Everyone taking part in
the study will be watched carefully for any side effects. If side effects occur, your health
care team may give you medicines to help reduce your discomfort. Most side effects
should resolve (go away) soon after stopping the testing procedure. In rare cases, side
effects can be serious, long lasting, or may never go away. As with any procedure,
there is always an extremely tiny risk of death. You should talk to your study doctor
about any side effects you experience while taking part in the study.

What are the risks specific to each part of the study?
The risks, benefits and options of your gastric bypass and gastric banding surgery have
been explained to you in detail and you will sign a separate Consent Form to undergo

CHR APPROVAL # H49493-28734-01 EXPIRATION DATE: 08/22/2008 PAGE 5 OF 9
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surgery. Again, both gastric bypass and gastric banding are part of your regular clinical
care.
Glucose/insulin infusion study: On rare occasions (less than 1%), infusion of insulin and
glucose may cause a burning sensation in the arm or symptoms of hypoglycemia (low
blood sugar; symptoms include blurred vision, nausea, headache, fatigue, rapid heart
rate, being more easily annoyed) or hyperglycemia (high blood sugar). The investigators
will monitor your blood sugar every 5 minutes during the study and also watch for any
symptoms. The infusion study will be discontinued if any symptoms occur.

Being in the GCRC (risks): There is a moderate risk of boredom from living in the
GCRC for about 1 and a half day at a time. Because all your activities must be
monitored by the nurses or other study personnel, you will lose some privacy while
participating.

Standardized weight reduction diet (risks): If the standardized diet is too drastic a
change for your body, you may feel some weakness while your system adjusts. The
type of diet used in this study has been used in clinical practice for many years and is
called a Very Low Calorie Diet. You can expect to lose 4-6 pounds per week, depending
on your starting weight and usual food intake. If you are in the ‘diet only’ group, you will
most likely experience hunger, especially the first several days. The hunger will lessen
throughout the study. You can help reduce the hunger by drinking as much plain water
and diet soft drinks as you need.

Radiation (x-ray) risks: The amount of radiation you will be exposed to during DEXA
scanning is relatively small. Such doses of radiation may be potentially harmful, but the
risks are so small that they are difficult to measure. If you have recently had a very
large number of x-rays or expect to become pregnant in the next 12 months, you should
discuss this with the study doctor before agreeing to be in this study.

Blood drawing (venipuncture) (risks): Drawing blood may cause temporary discomfort
from the needle stick, bruising, and infection. The total amount of blood drawn
throughout the study may cause a low blood count. The total amount of blood that will
be collected during the first month of the study is 200 mL or 6.7 oz or about 14
tablespoons, which is less than half of the amount that would be taken if you donated a
pint of blood. If you develop anemia (a low blood count) we would stop drawing your
blood and release you from the study. Every participant will receive long- term iron
supplementation as part of their regular post-operative care. You should refrain from
donating blood for a full 8 weeks before and after participating in this study.

Randomization (risks): You will be assigned to immediate surgery or diet followed by
surgery by chance. Since participating in the study will not affect the timing of your
surgery, the randomization involves no additional risk.

Unknown risks: The study procedures may have side effects that no one knows about
yet. The researchers will let you know if they learn anything that might make you
change your mind about participating in the study.

For more information about risks and side effects, ask your study doctor at any time.
CHR APPROVAL # H49493-28734-01 EXPIRATION DATE: 08/22/2008 PAGE 6 OF 9
VERSION 03/26/2008
Are there benefits to taking part in the study?
Taking part in this study may or may not make your health better. Most importantly, this
study will help us learn more about the exact effect gastric bypass and gastric banding
surgery has on the body. This information will help us make better decisions in the
future about who should get the operation, which operation is more appropriate for an
individual patient, and what steps we should take to make the operation most
successful after all our patients go home from the hospital.

What other choices do I have if I do not take part in this study?
You are under no obligation to participate in any part of our research program. Your
decision to participate will not adversely affect how we perform your operation or take
care of you afterward.

Will my medical information be kept private?
We will do our best to make sure that the personal information in your medical record is
kept private. However, we cannot guarantee total privacy. Your personal information
may be given out if required by law. If information from this study is published or
presented at scientific meetings, your name and other personal information will not be
used.
Organizations that may look at and/or copy your medical records for research, quality
assurance, and data analysis include: the UCSF Committee on Human Research; the
National Institutes of Health; and the Research Subjects’ Advocate, who works at the
GCRC.
Participation in research may involve a loss of privacy, but information about you will be
handled as confidentially as possible. A medical record will be created because of your
participation in this study. Your consent form and some of your research test results will
be included in this record. Therefore, your other doctors may become aware of your
participation. Hospital regulations require that all health care providers treat information
in medical records confidentially.

What are the costs of taking part in this study?
You will not be billed for participating in the research portion of this study. Your surgery
and the associated hospital stay at Moffitt-Long Hospital are not part of the research
study and will be billed to your insurance company, just as it is for all our non-research
patients. Financial counselors are available through the Moffitt-Long Hospital
accounting department to help should the need arise.

Do I get paid for participating in your study?
Yes. Because this study requires such a high level of commitment, we have modest
stipends for every participant. One check will be mailed to you about 4 to 6 weeks after
your participation in the study has ended. In return for your time, effort and travel
expenses, you will be paid $500 for completing the tests during the first 3-4 weeks of
the study (about 3-day GCRC admission for baseline and follow up testing and 14-day
diet at home). You will receive an additional $200 to complete the tests 6 months after
your surgery. Should you choose to withdraw before completion, you will be paid as
follows: $50 per day of admission to the SGFH-GCRC, $50 for completion of a Meal
Test and $50 for completion of glucose/insulin infusion study. Please note, this is a
stipend and not a paycheck. You will not be classified as an employee, will receive no
fringe benefits and will have no taxes deducted. However, the stipend may qualify as
CHR APPROVAL # H49493-28734-01 EXPIRATION DATE: 08/22/2008 PAGE 7 OF 9
VERSION 03/26/2008
reportable income for tax purposes. It is your responsibility to comply with all state and
federal tax regulations.

What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, Guilherme M Campos, MD, if you feel you
have been injured because of taking part in this study. You can tell the doctor in person
or call him at 415-353-2161.
Treatment and Compensation for Injury: If you are injured as a result of being in this
study, treatment will be available. The costs of the treatment may be covered by the
University of California, depending on a number of factors. The University does not
normally provide any other form of compensation for injury. For further information, you
may call the office of the UCSF Committee on Human Research 415-476-1814.

What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to
take part in the study. If you decide to take part in this study, you may leave the study
at any time. No matter what decision you make, there will be no penalty to you and you
will not lose any of your regular benefits. Leaving the study will not affect your medical
care. You can still get your medical care from our institution.
We will tell you about new information or changes in the study that may affect your
health or your willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to
seek payment by signing this form.

Who can answer my questions about the study?
You can talk to your study doctor about any questions or concerns you have about this
study. Contact your study doctor Guilherme M Campos, MD, at 415-353-2161.
If you have questions at any time, you can also call our study coordinator at 415-353-
2161.
For questions about your rights while taking part in this study, call the office of the
Committee on Human Research, UCSF's Institutional Review Board (a group of people
who review the research to protect your rights) at 415-476-1814.

CHR APPROVAL # H49493-28734-01 EXPIRATION DATE: 08/22/2008 PAGE 8 OF 9
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UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY

Insulin Sensitivity after Gastric Bypass, Adjustable Gastric Banding
and Caloric Restriction in Persons with Morbid Obesity: A Stratified,
Randomized, Controlled Pilot Trial.

Signature Page
(Version 03.26.2008)

You have been given copies of this consent form and the Experimental Subject's Bill of
Rights to keep.

You will be asked to sign a separate form authorizing access, use, creation, or
disclosure of health information about you.

PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to
participate or to withdraw at any point in this study without penalty or loss of benefits to
which you are otherwise entitled.

If you wish to participate in this study, you should sign below.

____________ _________________________________________
Date Participant's Signature for Consent

____________ _________________________________________
Date Person Obtaining Consent

CHR APPROVAL # H49493-28734-01 EXPIRATION DATE: 08/22/2008 PAGE 9 OF 9
VERSION 03/26/2008