Surgical Treatment for Diabetes Type 2

DSS-II International Guidelines

Metabolic surgery is now among the recommended
treatment options for type 2 diabetes among selectobese individuals

American Diabetes Association- Standards of Care 2017 (1)“Why surgery is the next big thing forType 2 Diabetes”“Surgery should be an option fordiabetics”

Nature (cover page) 26 May 26, 2016

time.com/4345470/gastric-bypass-surgery-diabetes/“One of the most significant changes intreating diabetes since the discovery of
insulin in 1921”“Metabolic Surgery for Type 2 Diabetes:
Changing the Landscape of DiabetesCare”

New Scientist, 28 May, 2016

Diabetes Care 2016 Jun; 39 (6): 857-860

The 2nd Diabetes Surgery Summit (DSS-II):an International Consensus Conference(2)

Rubino F, Nathan D, Eckel R et al. Diabetes Care 2016

• The DSS organising committee and the five partner diabetes organisations (ADA, IDF, Diabetes UK,CDS, Diabetes India) - tasked a group of 48 multidisciplinary international scholars to develop a setof evidence-based recommendations for surgicaltreatment of Type 2 diabetes (T2D).
• Two independent moderators coordinated theappraisal of evidence by the group. Rounds ofDelphi-like questionnaires were used to develop
consensus for 32 evidence-based conclusions.
Endocrinology/
Diabetology• Draft recommendations were open to publiccomment by other experts in the field and by theaudience at the 2015 World Congress of Interventional Diabetes Therapies in London.
• A face-to-face meeting of the expert committee
defined a final consensus document.
• Guidelines were submitted for formal ratification
by relevant professional organisations.

Surgery

InternalMedicine

Gastroenterology

25%

7%

2%

DSS-II expert
committee

Cardiology

2%• 48 members• 7 medical specialities• 14 countries

GeneralMedicine

2%

Nutrition

2%

Endocrinology/
Diabetology

Surgery

InternalMedicine

Gastroenterology

Surgical Treatment for Diabetes Type 2

What is Metabolic
Surgery?

“Metabolic surgery is defined as the useof gastrointestinal operations with theintent to treat T2D and obesity.” DSS-II (2)DSS-I

Modified from “Time to think differently
about diabetes.” Nature 2016 (3)2007

DSS-II
2015

2004

1955

Experimental evidence in rats
provides a mechanistic link
between gastrointestinal surgery& glucose homeostasis

Weight-loss(bariatric) surgeryintroduced

2016

Guidelines for surgicaltreatment of diabetes

1930

1940

1925-1950

Several reports document
diabetes resolution after
stomach surgery

1950

1960

1970

1980

1970-1995

1990

2000

2006-2007

Several reports consistentlydocument remission ofdiabetes after bariatric surgery

Clinical studies start to explore
the use of GI operations
expressly to treat diabetes

2010

2020

2008-2015

Publication of several randomised
trials demonstrates effects ofsurgical treatment of diabetes

A long road. Observations that Type 2 diabetes can be improved or even resolved by surgical operations
have been reported for almost a century. Reports in the early 1920’s showed that gastrointestinal (GI) operations for ulcers/cancer could cause dramatic improvement of diabetes. After the advent of bariatric surgery
in the 1950’s, observations of diabetes remission following GI surgery were increasingly reported.
Since the 2000’s, experimental evidence that changes in GI anatomy can directly influence glucose homeostasis provided a mechanistic rationale for the use of surgery as an intentional treatment of diabetes. DSS-Iand DSS-II assessed clinical evidence, including from numerous Randomised Clinical Trials (RCTs) performed
over the last decade, leading to current guidelines.

How does surgery
improve diabetes

Metabolic Surgery changes various mechanisms ofGI physiology involved in metabolic regulation (3, 4)

METABOLIC
SURGERY
GUT HORMONES

increasedinsulinsecretion

GUT MICROBIOTA
increasedinsulinsensitivity

BILE ACIDS

NUTRIENT SENSING

increasedsatiation &weight loss

“Given its role in metabolic regulation, the GI tract constitutes a clinically and biologicallymeaningful target for the management of T2D.” DSS-II (2)DSS-II International Guidelines

Clinical Evidence(2, 5)

11 randomised trials (RCTs - Level 1 Evidence) as wellas large, long-term case-controlled studies (level 2evidence) comparing surgery in overweight/obese
people with type 2 diabetes show that metabolic
surgery results in:greater improvement of glycemic control (Level 1evidence)
reduction of medication usage (Level 1 evidence)
reduction of cardiovascular disease (CVD) risk
(Level 1 evidence)
reduction of heart attacks, strokes, cancer andoverall mortality (Level 2 evidence)
greater weight loss (Level 1 evidence)With the introduction of laparoscopic (minimallyinvasive) approaches, multidisciplinary care models
and specialised high volume centers there has beena dramatic reduction of mortality and morbidityof bariatric/metabolic surgery over the past two
decades. Laparoscopic surgery also allows earlier
recovery from surgery and minimises hospital stay.

better quality of life (Level 1 evidence)

Randomised Clinical Trials

Surgery vs Lifestyle & Pharmacotherapy

Major improvement of Glycemia

Liang 2013

6BMI ≤ 35

Diabetic

Non-Diabetic
0136Months

9Parikh 2014Ikramuddin 2013
Ikramuddin 2015
Courcoulas 2014
Courcoulas 2015

12Halperin 2014
Ding 2015

Chance of Disease Remission: A substantial proportion of patients (between 30% and 60%, dependingon the procedure) experience durable (>5 year) normalisation of blood sugar levels without the need forongoing pharmacologic treatment (disease remission)

BMI > 35

HBA1C

Wentworth 2014

85Dixon 2008
Schauer 2012
Schauer 2014
Cummings 2015
Mingrone 2012
Mingrone 2015

Total

Cost Effectiveness: Economic analyses havealso shown that surgical treatments for diabetes are cost-effective, Cost per quality- adjusted life-year (QALY) is approximately $3,200- $6500,
well below $50,000/QALY (which is deemed appropriate for coverage).

0.001
RYGB LAGB VSG BPD

80Nosurgery Surgery

40
20
0Start ofClinical Trial

2 years later5 years later

Based on Migrone G. et al. Lancet 2015; 386 (9997): 964-973

1Meds & Lifestyle

101000Favors
Surgery

Reduction of CVD & Mortality Risk

Patients who do nothave surgery are more
likely to increase theiruse of injectables over time

40Controlpatients

30% Mortality% patients using insulin orother injectable medication

1000.1Favors

Based on Rubino F. et al. Diabetes Care 2016; 39, 861-877

Reduction of medication usage

60

Peto odds ratio

Ascending Mean Baseline BMI

Study (operations)

1020
1000

Surgicalpatients
2468Years after Surgery

1012

Based on Arterburn D. et al; JAMA. 2015; 313 (1): 62-70

Surgical Treatment for Diabetes Type 2

Indications for Surgical Treatment“There is now sufﬁcient clinical and mechanistic evidence to support inclusion of metabolic surgery among antidiabetes interventions for people with T2D and obesity.” DSS-II(2)Algorithm for patients with Type 2 Diabetes
Non-Obese

Obese

BMI < 30kg/m2 or 27.5 for Asians

BMI ≥ 30kg/m2 or 27.5 for Asians

ClassIII

Expedited
Assessment for
Metabolic Surgery

ClassIIClassI

Optimal lifestyle& Medical Rx

Optimal lifestyle & Medical Rx(incl. injectable meds & insulin)

GLYCEMIAGLYCEMIA

Poor
controlGood
controlPoor
controlGood
control

ConsiderMetabolic Surgery

Recommend
Metabolic Surgery
CLASS IBMI ≥ 30-34.9kg/m2 or 27.5-32.4 for Asians

CLASS IIBMI ≥ 35-39.9kg/m2 or 32.5-37.4 for Asians

NonsurgicalTreatmentCLASS IIIBMI ≥ 40kg/m2 or ≥ 37.5 for Asians

Based on Rubino F. et al. Diabetes Care 2016; 39, 861-877• “Metabolic surgery should be a recommended option to treat T2D in appropriate surgical candidates with class IIIobesity (BMI ≥ 40 kg/m2), regardless of the level of glycemic control or complexity of glucose-lowering regimens, aswell as in patients with class II obesity (BMI 35.0–39.9kg/m2) with inadequately controlled hyperglycemia despite
lifestyle and optimal medical therapy.” DSS-II (2)• “Metabolic surgery should also be considered to be an option to treat T2D in patients with class I obesity (BMI30.0–34.9 kg/m2) and inadequately controlled hyperglycemia despite optimal medical treatment by either oral orinjectable medications (including insulin).” DSS-II (2)• “All BMI thresholds should be reconsidered dependi ng on the ancestry of the patient. For example, for patients ofAsian descent, the BMI values above should be reduced by 2.5 kg/m2.” DSS-II (2)Contraindications“Contraindications for metabolic surgery include diagnosis of Type 1Diabetes (unless surgery is indicated forother reasons, such as severe obesity); current drug or alcohol abuse; uncontrolled psychiatric illness; lack ofcomprehension of the risks/benefits, expected outcomes, or alternatives; and lack of commitment to nutritional supplementation and long-term follow-up required with surgery.” DSS-II (2)DSS-II International Guidelines

Standard Metabolic Surgical Procedures
Evidence shows a gradient of efﬁcacy among the main four accepted surgical approaches for weight loss
and diabetes remission, as follows: BPD > RYGB > VSG > LAGB. The opposite gradient exists for comparative
safety of these operations. (2, 5)

Roux-en-Y Gastric
Bypass (RYGB)

Vertical Sleeve
Gastrectomy (VSG)

The stomach is divided, and asmall proximal pouch is created.
A gastro-jejunal anastomosis
is created. The remnant
stomach, duodenum andproximal jejunum areexcluded from thetransit of nutrients.
Bile and biliopancreatic juices are diverted
downward.

A vertical gastric resection isperformed along the smaller
curvature using staplers,leaving behind a “sleeveshaped” stomach,without rerouting
the intestine.

Laparoscopic
Adjustable GastricBanding (LAGB)

Biliopancreatic
Diversion (BPD)

An inflatable band isplaced around the upper
part of the stomach.
The band is adjusted
by injecting saline intoa subcutaneousport

The stomach is resectedhorizontally (classicBPD) or vertically(Duodenal Switch).
The duodenum,
jejunum, and partof the ileum arebypassed. Nutrientsand biliopancreatic
juices mix only
within the distal
50-100 cmof the ileum(commonchannel)

Surgical Treatment for Diabetes Type 2

Choosing the Surgical Procedure“Among the 4 accepted operations, RYGB appears to have a more favorable risk-beneﬁt proﬁle in most patients with T2D”. (2)“However, the choice of surgical procedure should be based on evaluation of the risk-to- benefit ratio in individual patients, weighing long-term nutritional hazards, previous abdominal surgery versus effectiveness on
glycemic control and CVD risk”. (2)Preoperative evaluation

A multidisciplinary
approachas recommended by the DSS-II expert group

Standard preoperational tests used for GI
surgery at individual providers’ institutions.

Patients’ eligibility for metabolic surgery should
be assessed by a multidisciplinary team including
surgeon(s), internist(s) or diabetologist(s) /endocrinologist(s), and dietitian(s) with specificexpertise in diabetes care.

Recent tests to characterise current diabetes
status, for example, but not limited to,
HbA1c, fasting glucose, lipid proﬁle, andtests for retinopathy, nephropathy, andneuropathy.

Metabolic surgery should be performed in specialised
high-volume centers with multidisciplinary teams
experienced inmanagement ofdiabetes and GI
surgery

Tests to distinguish T1D from T2D (fastingC-peptide; anti-GAD or other autoantibodies).

Side effects / complications
Safety of bariatric/metabolic surgery has improved
significantly over the last two decades, with continued refinement of minimally invasive approaches (laparoscopic surgery), enhanced training andcredentialing, and involvement of multidisciplinary
teams. Reported mortality risk is 0.1-0.5%, similar tohysterectomy, cholecystectomy or hip replacement.
Major peri-operative complications are uncommon,
ranging from 2 to 6%; minor complications occur
in up to 15%. Long-term surgical complications can(2, 5)also occur, with variable frequency and dependingon the type of procedure. They include but are notlimited to internal hernia/small bowel occlusion(RYGB, BPD), marginal ulcers and anastomotic
stricture (RYGB) and band slippage/erosion (LAGB),
Nutritional complications also vary in frequency andseverity depending on the type of procedure. Iron
deficiency is commonly observed; less common
complications include anaemia, bone fractures andpostprandial hypoglycaemia (+RYGB), steatorrhea/diarrhoea and protein calorie malabsorption (++BPD).

Follow-up“Postoperative follow-up should include surgical and nutritional evaluations at least every 6 months, andmore often if necessary, during the ﬁrst 2 postoperative years and at least annually thereafter.“ (2)Even if patients experience diabetes remission, monitoring of glycemic control should be continued with thesame frequency as recommended for patients with prediabetes because of the potential for relapse.(2)Long-term monitoring of micronutrient status, nutritional supplementation and support must be provided
to patients after surgery, according to guidelines by national and international societies.(2)Surgeon

DieticianEndocrinologist

Nurse

Annual follow-ups

operation

6121824months

monthsmonthsmonthsDSS-II International Guidelines

Partner diabetes organiSations of the DSS-II
American Diabetes Association
ADA

International Diabetes Federation
IDF

Diabetes UK
DUK

Chinese Diabetes Society
CDS

Diabetes India
DI

enDORSInG SOCIETIES OF The DSS-II COnSenSuS STATeMenTS & GuIDeLIneS(as of August 2017)

INTERNATIONAL ORGANISATIONSIDFInternational
Diabetes Federation

APBMSS
Asia-Pacific Bariatric andMetabolic Surgery Society

EASO
European Associationfor the Study of Obesity

IFSO
Int. Federation for the Surgery ofObesity & Metabolic Disorders

ALAD
Latin American Associationof Diabetes

NATIONAL ORGANISATIONS / SOCIETIES• Argentinian Society of Diabetes(SAD)• Argentinian Society for Bariatricand Metabolic Surgery (SACO)• Argentinian Society of Nutrition(SAN)• Australian Diabetes Society (ADS)• Belgian Diabetes Association(ABD)• Brazilian Society of Diabetes(SBD)• Brazilian Society of Bariatric andMetabolic Surgery (SBCBM)• Czech Society for the Study ofObesity (CSSO)• Chilean Society of Endocrinology
and Diabetes (SCED)• Chilean Society for Bariatric andMetabolic Surgery (SCCBM)• Chinese Diabetes Society (CDS)• Japan Diabetes Society (JDS)• Diabetes UK (DUK)• French Society of Diabetes (SFD)• Mexican College of Bariatric andMetabolic Surgery (CMCOEM)• Association of British Clinical
Diabetologists (ABCD)• British Obesity and Metabolic
Surgery Society (BOMSS)• French Society of Bariatric andMetabolic Surgery (SOFFCO)• German Diabetes Society (DDG)• Mexican Society of Nutrition and
Endocrinology (SMNE)• Society for Endocrinology (SfE)• German Society for Obesity
Surgery (CA-ADIP)• Portuguese Society ofDiabetology (SPD)• American Diabetes Association(ADA)• Hellenic Diabetes Association(HDA)• Qatar Diabetes Association (QDA)• American Association of Clinical
Endocrinologists (AACE)• Diabetes India (DI)• Saudi Diabetes and Endocrine
Association (SDEA)• American College of Surgeons(ACS)• Irish Endocrine Society (IES)• Slovakian Diabetes Society (SDS)• American Gastroenterological
Association (AGA)• Israel Diabetes Association (IDA)• Obesitology Section Slovakian
Diabetes Society (OS SDS)

• Italian Society of Bariatric &Metabolic Surgery (SICOB)• South African Society for Surgery
Obesity and Metabolism (SASSO)• Italian Society of Diabetology(SID)• Italian Society of Clinical
Endocrinologists (AME)• Spanish Society for Bariatric andMetabolic Surgery (SECO)• Spanish Society of Diabetes (SED)• American Society for Metabolicand Bariatric Surgery (ASMBS)• Endocrine Society• Society of American
Gastrointestinal and EndoscopicSurgeons (SAGES)• Society for Surgery of the
Alimentary Tract (SSAT)• The Obesity Society (TOS)DSS Co-directors:
Francesco Rubino (UK); David E. Cummings (USA); Lee M. Kaplan (USA); Phil R. Schauer (USA)

References(1) ADA Standards of Medical Care in Diabetes 2017 Diabetes Care; Jan 2017; vol. 40 issue Suppl.1(2) Rubino F. et al. Diabetes Care Diabetes Care 2016 Jun; 39 (6): 861-877(3) Rubino F. Nature 2016; 533(7604):459-61(4) Evers SS et al. Annu Rev Physiol. 2017 Feb 10;79:313-334(5) Cummings DE and Cohen R. Diabetes Care 2016 Jun; 39 (6): 924-933

DSS statement:
Rubino F, Nathan D, Eckel R et al.
Diabetes Care 2016 Jun; 39(6): 861-877
http://care.diabetesjournals.org/content/39/6/861

This brochure has been created with thesupport of King’s College London andthrough an unrestricted educational grantby Ethicon Endosurgery