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The Efficacy of Bariatric Surgery as

Treatment for Patients with Type 2


Diabetes
A Review of Literature

Kelly Lonergan
DHEC Dietetic Intern
2015

The Efficacy of Bariatric Surgery as


Treatment for Patients with Type 2
Diabetes
Introduction
Diabetes is a quickly growing disease, not only in the U.S., but all
over the world. Because of the strong link between diabetes and
obesity, the rates of diabetes are constantly increasing as our
general public becomes more and more overweight (Scott, 2013).
This is specifically true with Type 2 Diabetes as this type is most
often caused by patients weighing far above their ideal body
weight. Obesity and Type 2 Diabetes are expected to be the two
most widely seen health problems in the next few decades as well
(Dixon, 2008). A person with diabetes will often see higher blood
glucose levels in their blood. This is because the body is not using
its insulin properly or it simply isnt producing enough of it. This
insulin resistance is counteracted by the pancreas, which will
produce additional insulin to make up for the deficit. However,
over time the pancreas can no longer keep up with the dropping
insulin production and the blood glucose levels become high and
uncontrolled (Type 2, 2015). A balanced diet and consistent
exercise help to reduce the bodys insulin resistance.
The conventional treatment described later on is effective in
controlling blood sugars and weight management; however, the
treatment often fails due to patients incompliance. Improving the
health status of a patient with diabetes is important, but
improving their health status so much so that it puts their
diabetes into remission is much more ideal. Long term diabetes is
correlated with numerous other potential health problems
including hyperglycemia, hypoglycemia, hypertension, peripheral
nephropathy, diabetic retinopathy, heart attack, stroke, kidney
disease, potential amputation, and even death (Type 2 Diabetes,
2015). For this reason, it is vital to treat this disease as soon as
possible in order to minimize the negative effects.
A long used method for weight loss is bariatric surgery. The
question now may be asked that if obesity is part of the cause of
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diabetes, would the resolution of obesity also resolve diabetes?


(Scott, 2013). This review of various studies will help to determine
this answer. These bariatric surgeries are effective in weight loss
by using three major techniques: 1) restriction of the amount of
food allowed in the stomach, 2) malabsorption of nutrients, and 3)
both restrictive and malabsorptive processes acting together
(Bariatric, 2015). The different surgeries are listed below with
their procedure and outcomes. Each of these surgeries is used at
least once in the studies that will be presented.
Adjustable Gastric Band: A band is placed around upper
portion of stomach creating a small pouch that restricts
stomach volume. This causes slow, moderate weight loss,
but the surgery has the least complications.
Laparoscopic Sleeve Gastrectomy: Approximately 80% of the
stomach is removed leaving a tube shaped stomach portion
remaining. This causes fast, significant weight loss, a
decrease in appetite, and an increase in satiety.
Roux-en-Y Gastric Bypass: A 1 oz. portion of the stomach
remains after the majority of the stomach is separated and
bypassed and the newly formed small stomach is led directly
into the small intestine. This causes significant, long-term
weight loss, decreases appetite, and increases satiety. It
does however carry many complications and life-long
vitamin and mineral deficiencies.
Biliopancreatic Diversion with Duodenal Switch: Similar to
the sleeve gastrectomy, a large portion of the stomach is
removed; however, now about 3/4ths of the small intestine is
also bypassed by separation and reattachment. This results
in the greatest amount of weight loss, reduces appetite,
improves satiety, but it does have the highest risk of
complications and life-long vitamin and mineral deficiencies.

Conventional Treatment

The most widely used method of treatment for Type 2 Diabetes is


Medical Nutrition Therapy. This conventional method doesnt use
surgery as a means of weight loss, but rather diet counseling,
exercise recommendations, and medications if need be. This
conventional treatment is usually provided by an interdisciplinary
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team of a dietitian, a physician, a nurse, and a diabetes educator


(Mingrone, 2012). This type of treatment relies heavily on the
patients willingness to restrict certain foods and change many
aspects of their lifestyle. If the patient fully complies with their
dietitians directions, their diabetes can be well managed. These
lifestyle changes include reducing ones daily energy intake,
reducing overall fat intake, increasing high fiber foods, increasing
low-glycemic index foods, and encouraging 200 minutes of
physical activity per week (Dixon, 2008). Strategies may include
meal planning, carb counting, using a food diary, and using meal
replacement shakes on occasion. Diligent monitoring of the
patients blood sugars and HbA1c will assist the provider in
making adjustments to the patients treatment and to track their
progress. Should the addition of medications be required, the
patient may begin on oral diabetes medication or insulin
injections.

Review of Literature
Australia: Adjustable Gastric Banding and Conventional
Therapy for Type 2 Diabetes: A Randomized Controlled
Trial
This study focused on how two different treatments for T2DM
differed. It measured fasting glucose levels, glycated hemoglobin
value, weight loss, and other outcomes over a two year time
period. The goal of this study was to determine if surgical
interventions would lead to better glycemic control and less need
for diabetes medications than just the conventional method
alone. They placed a standard of diabetes remission at fasting
plasma glucose levels less than 126 mg/dL (6.99 mmol/L) and
HbA1c values less than 6.2%. Participants included were 60 obese
people with BMIs between 30 and 40 who had newly been
diagnosed with type 2 diabetes in the past 2 years or less. The
two trial groups were 30 people to receive conventional treatment
as described above and 30 people to receive bariatric surgery.
The surgery group members underwent laparoscopic adjustable
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gastric banding and were treated with conventional methods as


well post-operation.
The study resulted in impressive findings. The surgical group saw
a 76% remission rate and the conventional group saw a 15%
remission rate; thats 26 total people out of 60 that were
essentially cured of diabetes. This remission can be seen in the
improvements in HbA1c among the two groups as well. The
surgical groups average A1c dropped from 7.8% to 6.0% and the
conventional groups average dropped from 7.6% to 7.2%. Weight
loss was also a major outcome to be paid attention to. It is no
secret that weight loss drastically improves ones control of their
diabetes. The surgical group saw an average 21 lb. weight loss
while the conventional group only saw about 1.5 lbs. lost. In terms
of BMIs, a drop of 36.9 to 29.5 and 37.1 to 36.6 was seen in the
surgical and conventional groups respectively. So, it is clear that
both methods are effective, but treatments including surgery will
be more aggressive and will result in greater outcomes in a
shorter time period.

Although the surgical group saw greater outcomes than the


conventional group, it did come with some level of risk. Most
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patients saw no complications, but one patient had their band


removed after 15 days of eating difficulties and persistent
regurgitation. Another developed an infection at the access port
site, and two other people developed gastric pouch enlargement
10 months post-op.
The study concluded by stating that weight loss seemed to be the
best indicator for diabetes remission. Whether the weight loss
was done by conventional methods or the gastric banding
procedure, the greater the weight loss returned the greater
improvement in glycemic control. So, perhaps intensive weight
loss therapy is really the best treatment.

Italy: Bariatric Surgery versus Conventional Medical


Therapy for Type 2 Diabetes
This study was a nonblinded, randomized, controlled trial that
tested the rates of diabetes remission between three groups, a
medical therapy group (MT), a gastric bypass group (GB), and a
biliopancreatic-diversion group (BD). Sixty patients between 30
and 60 years old were included who had a BMI of 35+ and who
had diabetes for at least 5 years. Treatments for the three groups
varied, yet all included a multidisciplinary team who assisted in
the treatment and follow-ups at 1, 3, 6, 9, 12, and 24 months. The
MT group received individualized doses of oral hypoglycemic
agents and insulin, as well as diet plans and programs for lifestyle
changes. These included reduced energy and fat intake, increased
fiber intake, and increased physical activity regimens. A
diabetologist and a dietitian assisted these patients specifically.
The two surgical croups underwent their respective surgeries,
either the gastric bypass or the biliopancreatic-diversion. Along
with standard medical care, these patients also received
multivitamin and mineral supplementation as these surgeries
often cause deficits. Vitamin D and calcium were especially paid
attention to with the patients receiving the biliopancreaticdiversion procedure.
Different from the previous study, this study determined the level
of diabetes remission to be when fasting plasma glucose level
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was less than 100 mg/dL (5.6 mmol/L) and the glycated
hemoglobin was less than 6.5% for at least one year. The results
for this study were also surprising. The MT groups actually saw a
0% rate of diabetes remission after 2 years of treatment. On the
other hand, the GB group saw a 75% remission and the BD group
saw a 95% remission.

This study has a much greater discrepancy between the surgical


and non-surgical groups. The results of this study were taken even
further to estimate the approximate amount of time it takes to
reach remission. Although both surgical groups saw a very high
rate of remission, the BD group saw this remission over twice as
soon. The GB group averaged 10 months to reach remission while
the BD group only needed about 4 months. Similarly, all groups
saw some weight loss, but the surgical groups (~33 lb. loss) saw
much more than the medical therapy group (~5 lb. loss).
Unlike the previous study, these results also included changes in
the participants lipid profile. The group that continues to see the
greatest outcomes remains the BD group. These patients saw a
49% drop in total cholesterol (214 to 107 mg/dL), a 65% drop in
LDL cholesterol (132 to 48 mg/dL), and a 57% drop in triglycerides
(221 to 85 mg/dL).

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The studys discussion hypothesized that the reason for the BD


groups extreme outcomes is due to the fact that this procedure
causes a malabsorption of fat. This is why they saw the greatest
improvement in their lipid profiles; there is less cholesterol and
triglycerides circulating in the blood. This surgical method saw the
greatest immediate success; however, it also is expected to have
the greatest risk for nutritional deficiencies in the future. Overall,
this study helps to prove the idea that bariatric surgeries are a
more effective course of treatment than conventional medical
therapy alone.

Greece: Restoration of Euglycemia and Normal Acute


Insulin Response to Glucose in Obese Subjects with
Type 2 Diabetes Following Bariatric Surgery
Unlike the previous two studies, this study looked at varying
levels of insulin resistance. There were three study groups and
one control group which did not undergo any surgery. The three
study groups were the diabetes group (DM), the impaired glucose
tolerance group (IGT), and the normal glucose tolerance group
(NGT). All of these participants, who were all female, had an
average BMI of 53 and the control group had a normal BMI. The
study focused on the progressive decrease of the acute insulin
response (AIR) to glucose as one reaches the diabetes state when
AIR is finally lost.
The experimental group all received a combination bariatric
surgeryBPD with RYGBPor biliopancreatic diversion with Rouxen-Y gastric bypass, along with a cholecystectomy and
appendectomy. Post-op, the patients consumed a liquid diet of
600-800 calories per day for the first month. They were then
slowly advanced to a 1000-1200 calorie diet till the third month
when they were finally advanced to a 1500-2000 calorie diet. The
study carefully monitored its patients at post-op, 3, 6, and 12
months.
After the procedure, each patients BMI, fat mass, fat-free mass,
fasting plasma glucose, and AIR was measured and recorded.
Interestingly enough, all the groups showed a similar decrease in
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BMI, 24 kg/m for DM, 21.5 for IGT, and 18.2 for NGT. All groups
also saw their fasting plasma glucose levels normalize after the
first 3
months post-operation; this same result was seen with insulin
sensitivity. AIR also
improved
significantly
with
each group, and by
12 months post-op
all
groups
had
similar values. In
this
study,
the
patients
actually
saw a 100% rate of
remission no matter
which group they
were in. The surgery
helped to regain
normal AIR after just
3 months after the
operation
and
insulin
sensitivity returned to normal in this time period also. As seen in
Figure 2 to the right, each group saw their AIR normalize in the
first 3 months post-op and it continued to improve in the following
time after as well. The DM group saw their insulin response
increase to reach a normal level and both the IGT and NGT saw
their levels decrease to a level more comparable to the control
group (labeled C at the far right). However, the patients all
remained obese despite their incredible weight loss, the average
BMI was 30 kg/m. This outcome shows that perhaps dramatic
weight loss is the major factor for diabetes remission, but not
necessarily escaping obesity entirely.
The BPD with RYGBP helps aid in weight loss because it reduces
the total caloric intake that is able to be consumed each day. It
also decreases carbohydrate consumption and increases lipid
malabsorption. Because of this, these patients see weight loss, fat
mass loss, and improved lipid profiles. One important conclusion
that this study drew was that the loss of AIR when a patient
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reaches a diabetic state is not permanent; it can be reversed with


extreme treatment, likely being bariatric surgery. These
interventions can be valuable in treating varying degrees of
insulin sensitivity.

United States of America: Effect of Laparoscopic Roux-EnY Gastric Bypass on Type 2 Diabetes Mellitus
As opposed to open RYGBP, this study used Laparoscopic RYGBP,
which is less invasive and is associated with fewer complications.
The goal of this study was to determine if this surgery improved
ones diabetes up to four years post-op, which is the longest
timeline any of these studies have observed thus far. This study
also had the greatest participant pool by far at 240 patients
compared to the previous studies analyzed with 60, 60, and 25
people respectively. The study looked at similar outcomes
including weight loss, fasting plasma glucose, glycated
hemoglobin, diabetic medication requirement, and changes in
comorbidities. This study was more of an observational study that
viewed participants who had already gone through LRYGBP and
reviewed their health statuses periodically. The patients followed
up with the study every 3 months until weight stabilization, then
continued annually.
The participant pool was made up of patients between 14 and 74
years old with either a BMI of 40+ or a BMI of 35+ with
comorbidities. The pool was then divided into groups based on
duration of diabetes and severity. The duration groups were less
than 5 years with diabetes, 6-10 years, and 10+ years. The
severity groups were divided into impaired fasting glucose (IFG),
diet-controlled type 2 diabetes, oral agent users with type 2
diabetes, and insulin users with type 2 diabetes.
Post-operation, the diet consisted of clear liquids until it was
confirmed no leaks or obstructions resulted from the surgery. This
diet was continued for the first month until the patients were
advanced to solid foods. The standard for diabetes remission, or
return to normalization, in this study were for the HbA1c to drop
to below 6%, the fasting plasma glucose to be less than or equal
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to 110 mg/dL, and for the patient to no longer require


medications.

Unique to this study was the careful evaluation of comorbidity


improvements. The most common comorbidities the participant
pool experienced were hypertension, degenerative joint disease,
sleep apnea, hypercholesterolemia, hypertriglyceridemia,
depression, and GERD. This study did look at the rate of diabetic
remission, but it also looked at the level of improvement or
remission of these other health problems often associated with
diabetes.
In terms of the severity-divided groups, the IFG group saw a 73%
excess weight loss, the diet-controlled T2DM group saw 65%
weight loss, the oral agent using T2DM group saw a 57% weight
loss, and finally the insulin T2DM group saw a 59% weight loss.
The duration-divided groups all saw a similar loss of excess
weight at about 60%. For all participants, the average fasting
plasma glucose dropped from 187 to 100 mg/dL and the HbA1c
from 8.2% to 5.5%.

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In general, the patients with the milder severity saw greater


improvements than the most severe insulin-dependent diabetes
patients. In terms of diabetes medication, the study saw an 87%
reduction in the number of patients using medications, and of the
remaining patients, they saw a great reduction in dosage. Overall,
every single patient saw great improvements if not resolution of
their diabetes; 83% of patients saw complete diabetes remission.
The most successful patients were those who had diabetes in the
least severe state or for the shortest duration. The following table
shows the degrees of severity and duration compared to their
rates of improvements or resolutions.
Number of Patients = 191
Severity
IFG = 14
Diet-controlled T2DM = 32
Oral agent using T2DM =
93
Insulin dependent T2DM =
52

Improved = 33

Resolved = 158

0%
3%

100%
97%

13%

87%

38%

62%
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Duration
5 years or less = 119
6 to 10 years = 44
10+ years = 28

5%
25%
46%

95%
75%
54%

The degree of comorbidity improvement was also impressive.


36% of patients saw their hypertension resolve, 37% saw their
hypercholesterolemia resolve, 33% saw their sleep apnea resolve,
diabetic neuropathy was also significantly improved in 50% of
patients.
In conclusion, this study again claimed that weight loss is the best
treatment for diabetes regardless of how it is achieved.

Sweden: Bariatric Surgery and Prevention of Type 2


Diabetes in Swedish Obese Subjects
Again, this study pushed the trial parameters past the previous
ones analyzed. This Swedish study looked at an impressive 3,429
participants, 1,658 surgical and 1,771 control, for a long follow-up
time period of 15 years. This large participant pool and long
observation time facilitates more accurate conclusions and
expectations for the future. Unlike the previous studies, this study
looked at obese patients, none of whom had diabetes at the start.
These patients ranged from 37 to 60 years old, and had a BMI of
34+ for men and 38+ for women. This surgical group was further
divided into 3 groups to receive different surgeries, 311 for gastric
banding, 1140 for vertical banded gastroplasty, and 207 for
gastric bypass. After the operation, these patients were followedup with at 6 months, 1, 2, 3, 4, 6, 8, 10, and 15 years post-op for
physical examinations, lab work, and questionnaires.
In the follow-ups, diabetes developed in a total 502 patients, or
15%; 392 of these from the control group and 110 of these from
the surgical group. This may lead one to draw the conclusion that
the surgery is causing the diabetes. However, without the surgery
it is expected that some of those people would have developed
diabetes later in life. In this case the surgery was used more as a
preventative measure. As stated previously, after 15 years, 392
people who never had surgery developed diabetes while only 110
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people did develop it who did have the surgery. The study
concluded that bariatric surgery can reduce the incidence of type
2 diabetes by 78% in obese patients.
The interesting thing about this study is that it is looking at the
preventative effect bariatric surgery has on diabetes
development, not the treatment of existing diabetes. This is a
valuable study because it could save people from the other
comorbidities that are commonly associated with diabetes. If
someone is obese, their chances for developing diabetes rise
exponentially. However, if this same person undergoes some form
of bariatric surgery, their risk is dramatically lowered.

United States of America: Bariatric Surgery versus


Intensive Medical Therapy in Obese Patients with
Diabetes
Similar to some of the studies previously described, this study
compared medical therapy alone to a treatment of surgery plus
medical therapy. 150 patients were included, 100 of whom
underwent bariatric surgery. Half of these surgical patients
received gastric bypass and the other half received a sleeve
gastrectomy. The total participant pool was comprised of 20 to 60
year olds with type 2 diabetes who had a BMI between 27 and 43.
The goal of treatment was to bring these patients HbA1c levels
down to below 6.0%. This study also had standards to reach for
blood pressure (130/80 mm Hg) and LDL cholesterol (100 mg/dL).
These patients underwent their laparoscopic procedures after
much evaluation and assessments. Post-operation, they were
supplemented with multivitamins, iron, vitamin B12, calcium
citrate, and vitamin D. They were also continuously assessed for
nutritional deficiencies to ensure new health problems didnt
arise. The researchers also collected data on the patients weight,
waist and hip circumference, blood pressure, glycated
hemoglobin, and fasting plasma glucose at set time frames
throughout the study.

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The results of the study hardly differ from the previous studies
conclusions. The medical therapy did see some improvement with
12% of people reaching the target A1c of 6.0%. However, it is no
surprise that the surgical groups saw much more impressive
results. The gastric bypass group had 42% of people reach the
target and the sleeve gastrectomy group saw 37% of people do
the same. These two values are somewhat comparable; however,
those who achieved the 6.0% in the gastric bypass group did so
without the help of any diabetes medications. Similarly, weight
loss averaged about 26 lbs. between the two surgical groups
while the medical therapy group only saw about 5 lbs. lost on
average. One key finding was that the gastric bypass group saw
an extreme drop in their triglycerides, while the other two groups
saw a small change. As one can deduce from the charts below,
the gastric bypass group saw the greatest outcomes in all four
categories focused on.

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Their average HbA1c dropped from 9.3% to 6.4%, their FPG


dropped from 193 mg/dL to 99 mg/dL, their diabetes medications
dropped from 2.6 to less than 1, and their BMI dropped from 27 to
an impressive 26.8 all in one year. Not only are these results
impressive, but they were reached without any deaths,
hypoglycemic episodes, malnutrition, or excessive weight loss.

The main conclusion that can be drawn from this data is that
medical therapy alone can improve ones diabetes; however, the
effects would be much more intense if the therapy is assisted by a
bariatric surgery, specifically gastric bypass. Also, diabetes
medications were either eliminated or reduced when surgical
intervention was present. This not only saves the patient money,
it improves their quality of life. Overall, this study provides further
evidence that bariatric surgery can be a valuable strategy in
treating those with type 2 diabetes.

Conclusion
Throughout the review of all of these studies, it is clearly
suggested that one with type 2 diabetes should seek treatment in
the form of bariatric surgery. Specifically, it seems that Roux-En-Y
Gastric Bypass surgery is the most effective when tied with
intensive medical therapy. Not only do patients receiving this
treatment see great improvements, some even see their diabetes
disappear. Hundreds of patients from all of these studies
combined saw their diabetes go into remission completely. This is
important because the medical costs associated with diabetes
and the comorbidities that often go along with it are high and
ongoing (Dixon, 2008). The surgery itself will be a major expense,
but the hope is that it will save future continuous medical and
pharmacy bills. An estimation in 2012 stated global spending on
diabetes will be at least $490 billion by 2030 (Mingrone, 2012). By
then, this cost could be incredibly reduced if new, innovative
treatments for diabetes are researched and utilized.
One major limitation that presented in all studies was the length
of time that a patient had diabetes. Many studies focused on
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people how had been diagnosed with diabetes in the previous 2-5
years. One study did compare the surgical interventions effects
with diabetes duration and did find that newer diabetics had the
most success (Schauer, 2003). The results in all of these studies
can easily be translated to future newly diagnosed diabetics, but
what about those whove had the disease for 10 years or more?
These results may not apply to those with a longer history of the
disease due to deterioration of -cell function (Dixon, 2008).
These individuals may have reached past the point of the bodys
ability to reverse the effects of diabetes.
For this reason, further research should be conducted to
determine what the point-of-no-return is for diabetes and cells. Researchers should look further into how the body degrades
by its diabetes and how the -cells become less and less
effective. It is absolutely important to prevent diabetes from
occurring in the first place, but is it not equally important to help
those whove already been struck by the disease long ago? In the
United States, Type 2 diabetes is the leading cause of blindness,
renal failure, and amputation, and 70% of diabetic patients die of
cardiovascular disease, (Schauer, 2003). These complications
typically dont happen to the newly diagnosed, they occur in
patients whove had the disease for nearly a decade. Because of
this, it is important to stop diabetes not only when its just getting
started, but also when it has caused years and years of wreckage.

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