Amelioration of Diabetes Mellitus Type II after Sleeve Gastrectomy—Data on Nationwide Survey on Quality Assurance in Bariatric Surgery in Germany

doi:10.4236/ss.2013.412A002

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Surgical Science, 2013, 4, 8-12

Published Online December 2013 (http://www.scirp.org/journal/ss)

http://dx.doi.org/10.4236/ss.2013.412A002

Open Access SS

Amelioration of Diabetes Mellitus Type II after Sleeve

Gastrectomy—Data on Nationwide Survey on Quality

Assurance in Bariatric Surgery in Germany*

I. El-Sayes1, R. Weiner1, M. Talai Rad2, S. Wolff3, C. Knoll4, T. Manger5,6, C. Stroh5,6,7#

1Sachsenhausen Hospital, Frankfurt, Germany

2Helios Hospital, Bad Saarow, Germany

3Department of General, Abdominal and Vascular Surgery, University Hospital Magdeburg, Magdeburg, Germany

4Stat Consult, Magdeburg, Germany

5Department of General, Abdominal and Paediatric Surgery, SRH Hospital, Gera, Germany

6Institute of Quality Assurance in Surgery gGmbH, University Magdeburg, Magdeburg, Germany

7Competence Network Obesity, Germany

Email: #[email protected]

Received August 19, 2013; revised September 17, 2013; accepted September 25, 2013

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Introduction: Sleeve Gastrectomy (SG) is becoming more popular due to its weight reducing effect and promising

anti-diabetic efficacy. However, long term results are still lacking. Methods: The study focuses on anti-diabetic effi-

cacy of SG through retrospective analysis of data for patients who underwent SG in Germany from 2005 to 2011.

Anti-diabetic efficacy was assessed at 1, 2 and up to 4 years after surgery. Results: 5400 morbidly obese patients un-

derwent SG. Of these 5400 patients 13.2% (n = 712) were insulin treated (IT) and 21.6% (n = 1165) were non-insulin

treated (NIT). Total follow-up was accomplished in 41.24% of patients. Percentage of remission and improvement (RI)

at 1 year was 83.8% (80.2% for insulin treated (IT) vs. 85.1% for non-insulin treated (NIT)). RI% at 2 years dropped to

77.6% (76.9% for IT vs. 77.9% for NIT patients). With late follow up (up to 4 years), RI% was 65.9% (58.8% for IT vs.

66.7% for NIT patients). Difference between IT and NIT patients was insignificant. Conclusion: SG shows promising

ant-diabetic efficacy at 1 year, 2 years and up to 4 years after surgery. This efficacy gradually drops with prolonged

time interval after surgery and seems to be insignificantly higher among NIT vs. IT patients.

Keywords: Sleeve Gastrectomy; Diabetes Mellitus Type II; Diabetes Remission; Metabolic Surgery

1. Introduction

Sleeve Gastrectomy (SG) was initially described as the

first step of biliopancreatic diversion with duodenal

switch in super obese patients [1]. Recently, stand-alone

SG is gaining worldwide popularity, being a relatively

non-technically demanding procedure with excellent re-

sults, in terms of substantial weight loss. Accordingly,

SG is now approved as a definitive treatment in patients

with a body mass index (BMI) >40 kg/m2 or BMI >35

kg/m2 in diabetic patients [2-4]. This is due to the fact

that SG has an extended spectrum of action which covers

additional satisfactory improvement of diabetic state [2-

4]. It has also been proposed with encouraging results for

diabetic non-morbidly obese patients with optimistic

outcome [2-4]. Being a relatively recent technique, long

term effect of SG is currently under research. This na-

tionwide survey demonstrates long term anti-diabetic ef-

ficacy of SG in morbidly obese Germans who underwent

SG from 2005 to 2011.

2. Patients and Methods

*Conflict of interest: German Bariatric Surgery Registry is supported

by BMBF with No. 01GI1124.

The corresponding author confirms no links to these firms. The topic is

resented in an independent light and the information outlined is pro-

duct neutral.

#Corresponding author.

Patient selection: This data pool includes morbidly obese

Germans who underwent SG between 2005 and 2011 in

107 hospitals cooperating with the German Bariatric Sur-

gery Registry (GBSR), Institute of Quality Assurance in

I. EL-SAYES ET AL. 9

Surgery at the Otto-von-Guericke University of Magde-

burg [5]. Data were collected in a prospective manner.

That is to say, every year a new sample of population is

added to the already existing cohort. After complete data

collection, retrospective statistical analysis was done.

Inclusion criteria conformed to the National Institutes of

Health Consensus criteria [6]. The term (diabetes) refers

to a clinical status with a fasting plasma glucose level of

more than 126 mg/dl [7].

Assessment of diabetic profile was done at 1, 2 and up

to 4 years after SG. Accordingly, patients fell into one of

four presentations, namely: remission, improvement, no

change and deterioration. Remission, which can be either

partial (improvement) or complete, was defined as

achieving glycaemia below the diabetic range (126 mg/dl)

in the absence of active pharmacologic (anti-hypergly-

cemic medications, immunosuppressive medications) or

surgical (ongoing procedures such as repeated replace-

ments of endoluminal devices) therapy [8].

3. Statistical Analysis of Data

Statistical analysis was performed by Stat Consult GmbH

using SAS 9.2 software program. Descriptive statistical

analysis was specified by presentation of absolute and

relative frequencies for nominal values and mean, stan-

dard deviation, minimum and maximum values for con-

tinuous variables. Median was considered for high varia-

tion. Descriptive statistics were extended by frequency

tests for several values and variables. For further verifi-

cation of the differences between the variables χ2-test

was used. Significant differences are shown if p < 0.05.

Continuous variables of two groups were compared with

two sample t-Test.

4. Results

The study included 5400 morbidly obese patients who

underwent SG from 2005 through 2011. Their demo-

graphic data are demonstrated in Table 1. Of these 5400

patients who underwent SG 13.2% were insulin treated

(IT) vs. 21.6% who were non-insulin treated (NIT). All

these patients suffered on diabetes mellitus type II. Fol-

low up was successfully accomplished in 34.7% patients

after one year, 10.4% at two years and for 3.4% for pa-

tients up to 4 years. Those represent our cohort. This

relatively low follow up rate is due to the fact that follow

up program is not covered by the health insurance system

in Germany.

Patients are divided in two major groups according to

the anti-diabetic efficacy of SG: patients who show either

remission or improvement of their diabetic status (RI)

and those who show either no change of their diabetic

status or deterioration (ND). Remission was defined of

total loose of diabetes mellitus type II independent if the

patient was treated with insulin or oral anti-diabetics.

Several categories were defined patients could have a

reduction of insulin dose at all, a reduction of the oral

doses as well as a change from insulin to non-insulin

treated diabetes type II. Also some patients developed

diabetes in spite of weight reduction in case of better

medical examinations. Table 2 illustrates all these changes

as well as RI% among patients (total, IT and NIT) after

SG at 1, 2 and up to 4 years (Table 3 ). RI% was higher,

but statistically insignificant among NIT vs. IT patients

at all follow up points.

Data on duration of diabetes prior to surgery were not

available for these patients.

5. Discussion

Weight gain has always been referred to as a risk factor

for impaired glucose tolerance. Moreover, anti-diabetic

agents are usually associated with weight gain [9]. This

twin association of diabetes and obesity was the corner

stone for many studies centered upon simultaneous con-

trol of both metabolic disorders. Conservative methods

proved to lack long-lasting efficacy [10]. Surgery seems

therefore to be the most suitable alternative [10].

Among variable surgical options, SG has recently

emerged as a possible remedy for both diabetes and obe-

sity. Anti-diabetic effect of SG has even been proved to

precede its weight reducing effect [11]. Being a relatively

recent procedure, proper explanation of its mechanism of

action is currently under research. It is suggested that SG

is not simply an absolute restrictive maneuver. Fundus

Table 1. Demographic data of morbidly obese diabetics who

underwent SG in Germany from 2005 through 2011 and

incidence of associated co-morbidities.

 Gender:

 Males 1965 (36.4%)

 Females 3435 (63.6%)

 Mean age in years: 43.6

 Males 44.7

 females 42.9

 Mean BMI in kg/m²: 52.1

 Males 53.2

 Females 51.5

 Percentage of patients with

associated co-morbidities

(other than diabetes mellitus): 89.7%

 Hypertension 65.9%

 Skeletal diseases 49.8%

 Sleep apnea 26.9%

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Table 2. Changes of diabetes mellitus type II at 1, 2 and up to 4 years after SG for IT, NIT patients and for the total cohort.

At least one follow-up At one year (0.5 - 1.5 years)A t two years (1.5 - 2.5 years) Up to four years (>2.5 years)

N (%) N (%) N (%) N (%)

Patients with follow-up 2227 (41.2%) 1873 (34.7%) 559 (10.4%) 131 (2.4%)

After one year After two years Up to four years

(%) BMI (kg/m2) (%) BMI (kg/m2) (%) BMI (kg/m2)

Reduction of insulin

IT patients 40.9 (n = 99)−12.95 (±5.24) 39.7 (n = 31) −15.76 (±6.63) 17.7 (n = 3) −19.81 (±4.48)

Change from IT to NIT

IT to NIT patients 4.6 (n = 11)−13.80 (±3.70) 6.4 (n = 5) −16.93 (±6.85) - -

New onset of IT

IT patients 2.1 (n = 5) −7.65 (±10.75) 5.1 (n = 4) −12.50 (±5.60) - -

Reduction of oral anti-diabetics

NIT patients 34.8 (n = 152) −13.84 (±5.84) 18.0 (n = 22) −13.28 (±5.85) 22.2 (n = 6) −11.73 (±5.50)

Change from NIT to IT

NIT to IT patients 0.9 (n = 4) −11.00 (±3.68) 0.8 (n = 1) −5.93 (-) - -

New onset of NIT

NIT patients 0.7 (n = 3) −8.22 (±4.19) 0.8 (n = 1) −6.57 (-) 11.1 (n = 3) −13.88 (±6.88)

Remission and improvement (RI)

Total diabetics 83.8 −14.48 (±5.71) 77.6 −16.17 (±7.01) 65.9 −15.40 (±6.41)

IT patients 80.2 −14.15 (±5.96) 76.9 −16.03 (±6.51) 58.8 −20.18 (±6.72)

NIT patients 85.1 −14.63 (±5.62) 77.9 −16.19 (±7.35) 66.7 −11.95 (±4.98)

IT: insulin treated, NIT: non-insulin treated.

Table 3. Follow-up rate of patients at 1, 2 and up to 4 years after primary SG.

At least one follow-up At one year (0.75 - 1.25 years)At two years (1.75 - 2.25 years) Up to four years (>2.25 years)

N (%) N (%) N (%) N (%)

Patients with follow-up

2 227 (41.2%) 1 837 (34.7%) 599 (10.8%) 131 (2.4%)

IT: insulin treated, NIT: non-insulin treated.

resection, with resultant reduction of orixegenic ghrelin

hormone, results primarily in post-operative weight loss.

However, ghrelin hormone proved as well to have dia-

betogenic effect [12]. This together with rapid gastric

emptying, shorter bowel transit time and post-operative

rise of serum incretins (glucagon-like-peptide-1 and pep-

tide-YY) seem to augment its anti-diabetic effect [13,14].

These findings could partly explain the anti-diabetic ef-

fect of SG.

Although this potential to control diabetes seems to be

higher with RYGB if compared to SG [15,16], SG seems

however to have promisingresults. An efficacy of 88%

was observed in less than one year after SG in diabetic

patients [17]. This group of patients required only 6

months to achieve a mean HbA1C level of 6%. Our re-

sults go in accordance. Within one year after surgery,

83.8% of our patients had RI of their diabetic state.

Ruiz-Tovar et al. noticed that 83.3% of patients dis-

continued their hypoglycemic medications within one

month after SG. These findings were maintained for 24

months after surgery [18]. In this survey, a more or less

stationary RI% was noticed at midterm follow up inter-

vals of 2 years after SG, where RI% dropped slightly to

79.5%.

SG is the newest member among all obesity proce-

dures. Long-term efficacy of SG is therefore currently

lacking. However, some reports in literature studied the

anti-diabetic efficacy of SG five years after surgery and

attributed normalization of fasting blood sugar and

HbA1C encountered in 76.9% of their patients to SG

I. EL-SAYES ET AL. 11

[19]. We noticed that 65.9% of our patients maintained

their diabetes free state with long-term follow up interval

(up to 4 years). Abbatini et al. in analysis of long term ef-

fects of SG noticed an anti-diabetic efficacy, starting by

87.8% one year after surgery, gradually decreasing to

84.6% at two years and further dropped to 76.9% at five

post-operative years. Similarly our cohort showed that

83.8% of patients achieved RI within 1 year after SG.

This percentage dropped gradually to 77.6% at 2 years

and 65.9% up to 4years after operation respectively.

Reports about anti-diabetic efficacy of SG highlighted

a clinical situation of persisting diabetes after operation.

This could be encountered in type 1 insulin treated dia-

betics with autoimmune destruction of pancreatic beta

cells. It is therefore recommended to exclude this condi-

tion before surgery to optimize surgical outcome [20].

Schauer et al. similarly noticed an 87% reduction in the

number of patients requiring oral anti-diabetic medica-

tions after surgery vs. only 79% reduction among the

insulin requiring group [21]. In the same way, NIT pa-

tients in our cohort showed a higher RI% than IT at all

follow up intervals. This difference was statistically not

significant.

Although this report demonstrates in our opinion long

term outcome of a relatively recent surgical procedure,

which is lacking in most published studies, our database

lacks however accurate assessment of pre- and post-op-

erative HbA1C levels. This is a limitation in this survey.

Moreover, the follow up rate for our patients is relatively

low. However, this is attributed to the fact that follow up

of patients is not covered by health insurance service in

Germany.

6. Conclusion

In conclusion, SG is rapidly expanding in Germany, due

to its promising results in terms of post-operative weight

loss. Its anti-diabetic efficacy, even in IT patients, seems

also to play a role in its growing popularity. However,

long term assessment of its anti-diabetic efficacy is cur-

rently under evaluation.

7. Acknowledgements

We thank the following firms for financially supporting

the study: Johnson & Johnson MEDICAL GmbH, Ethi-

con Endo-Surgery Deutschland, Norderstedt Covidien Deu-

tschland GmbH, Neustadt/Donau Pharm-Allergan GmbH,

Ettlingen.

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