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Surgery for Obesity:Duodeno-Jejunal Bypass for Type 2 Diabetes
in Non-Obese – a Cure ?
George S. Ferzli, MD, FACSChairman of Surgery, Lutheran Medical CenterProfessor of Surgery, SUNY HSCBrooklyn, New York, USA
Derived from Center for Disease Control and Prevention website www.cdc.gov
Percent of Obese (BMI ≥ 30) in US Adults
Derived from Center for Disease Control and Prevention website www.cdc.gov
Percent of Obese (BMI ≥ 30) in US Adults
Period or Decades Incidence of Surgery Reason for Change
Late 1970’s Early 1980’s
25,000 procedures per year
Innovative procedures• gastroplasty• loop GBP• jejuno-ileal bypass
Late 1980’s1990’s
5,000 procedures per year
Multifactorial:• High M&M• Ineffective long-term• Perceived failure• Surgeon experience
2000’s80,000 to 110,000 procedures per year
Multifactorial:• Laparoscopy• Long-term data• Centers of Excellence
1.National Hospital Discharge Survey Public-use data file and documentation. Multi-year data CD-ROM. National Center for Health Statistics, 1979-1996.2.Nguyen et al. Accelerated growth of bariatric surgery with the introduction of minimally invasive surgery. Arch Surg 2005; 140: 1198-202.3.Griffen et al. The decline and fall of the jejunoileal bypass. Surg Gynecol Obstet 1983; 157: 301-8.4.Shirmer et al. Bariatric Surgery Training: Getting Your Ticket Punched. J Gastrointest Surg 2007;11: 807-12.
Popularity of Surgical Management
Current Procedures
Metabolic Syndrome
Also Known as:1. Syndrome “X”
2. Insulin Resistance Syndrome
3. Reaven’s Syndrome
4. CHAOSCoronary Artery DiseaseHypertensionAdult Onset DiabetesObesityStroke
Obesity Associated Conditions
Diabetes
Hypertension
Sleep apnea
Congestive heart failure
Hyperlipidemia
Stroke
Coronary artery disease
Osteoarthritis
Gastroesophageal reflux disease
Non-alcoholic fatty liver
Psychological disturbances
Diabetes
• Considered major public health problem – emerging as a world wide pandemic. In 1995 ~ 135 million people worldwide
• Expected to rise to close to 300 million by 2025 • CDC (2008) cases of diabetes have increased to 15% in just the past
two years • 2002-Annual direct health care cost was estimated to be $132 billion
in US • Complications
– Peripheral vascular disease (PVD) accounts for 20-30% – 10% of cerebral vascular accident – Cardiovascular disease accounts for 50% of total mortality – Retinopathy, ESRD
1. Venkat et al Diabetes–a common, growing, serious, costly, and potentially preventable public health problem. Diabetes ResClin Pract. 2000; 5 (Suppl2): S77–S784.2. H. King et Global burden of diabetes, 1995-2025: prevalence, numerical estimates and projections. Diabetes Care 21 (1998)1414-1431.3. CDC website @ www.CDC.com
Prevalence of Diabetes
• From 1980 through 2005, the number of adults aged 18-79 with newly diagnosed diabetes almost tripled from 493,000 in 1980 to 1.4 million in 2005 in the United States
• Annual number (in thousands) of new cases of diagnosed diabetes among adults aged 18-79 years, United States, 1980–2005
Studies Type and Size Effect on WeightEffect on
Comorbidities
Buchwald et al.Meta-analysisn = 22,094 pts
Mean excess weight loss: 61%
Resolution of: • Diabetes: 70%• HTN: 62%• Sleep apnea: 86%
Swedish Obese Subject trial (SOS)
Prospective matched cohortn = 4,047 pts
At 10 years:• Med: 1.6% gain•Surg: 16% loss
Improved by surgery:• Diabetes• Lipid profile• HTN• Hyperuricemia
1. Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA 2004; 292: 1724-37.
2. Sjostrom L, Lindros AK, Peltonem M, Torgerson J, Bouchard C, Carlsson B, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med 2004; 351: 2683-93.
Long-term Weight Control Analysis
Schauer et al.Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus.
Ann Surg. 2003 Oct; 238(4): 467-84
• 1160 patients underwent LRYGBP 5-year period
• LRYGBP resulted in significant weight loss (60% percent of excess body weight loss) and resolution (83%) of T2DM
• Fasting plasma glucose and HBA1C normalized (83%) or markedly improved (17%) in all patients
• Patients with the shortest duration and mildest form of T2DM had a higher rate of T2DM resolution after surgery– suggesting that early surgical
intervention is warranted to increase the likelihood of rendering patients euglycemic
Biliopancreatic Diversion (BPD)
• 312 BPD, obese patients with type 2 DM were followed for pre and postoperative serum glucose, triglycerides, cholesterol & arterial pressure measurements
• After BPD, fasting serum glucose fell within normal values in 310 patients; remained normal up to 10 years in all but 6 patients
• Evidence of hypertension disappeared in majority of patients
• Glycemic control translates into a reduced mortality for these patients as well as a low frequency of death from cardiovascular events
TRUE CLINICAL RECOVERY
Scopinaro N, Marinari GM, Camerini GB et al. Specific Effects of Biliopancreatic Diversion on the Major Components of Metabolic Syndrome. Diabetes Care. 2005. 28:2406-2411
Dixon et al.Adjustable Gatric Banding and conventional therapy for type 2
diabetes: a randomized control trial JAMA 2008
• Un-blinded randomized control trial
• 60 obese patients (BMI >30 & <40) with T2DM
• Interventions:
-Conventional diabetes control with lifestyle modification vs. LAGB
• Results:-55 (92%) completed with 2 year follow-up
-Remission of diabetes was achieved in 73% in surgical group and 13% in the conventional-therapy group
Dixon et al.Adjustable Gatric Banding and conventional therapy for type 2
diabetes: a randomized control trial JAMA 2008
• CONCLUSIONS: • Participants randomized to surgical therapy were
more likely to achieve remission of type 2 diabetes through greater weight loss.
• These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed.
Rates of Remission of Diabetes
Adjustable
Gastric Banding
Roux-en-Y
Gastric Bypass
Biliopancreatic
Diversion
>95%(Immediate)
48%(Slow)
84%(Immediate)
“Gastric bypass and biliopancreatic diversion seem to achieve control of diabetes as a primary and
independent effect, not secondary to the treatment of overweight.”
Potential of Surgery for Curing Type 2 Diabetes Mellitus. Rubino, Francesco, MD; Gagner, Michel MD, FACS, FRCSC Annals of Surgery; 236 (5): 554-559, November 2002
2002: Antidiabetic Effect of Bariatric Surgery: Direct or Indirect?
1995-“Who Would Have Though It?Pories et al. Annals of Surgery
• NIDDM is no longer an uncontrollable disease
• The correction on NIDDM occurs within days following gastric bypass, long before significant weight loss has occurred
• Decrease caloric intake and changes in incretin stimulation of the islets by the gut may play a role
Historical Perspective• 1955- Friedman
– 3 patients with poorly control DM – 3-4 days after subtotal gastrectomy: all 3 pateints showed an improvement in their
DM • Occurred sooner than associated weight loss• Patients later regained their weight without an associated loss of glucose
control or glycosuria
• Mingrone 1977 : Case report – Young, non obese woman with DM who underwent BPD for chylomicronemia– Plasma insulin and blood glucose levels normalized within 3 months
• Bittner –1981- subtotal gastrectomy and gastrointestinal reconstructions that excluded duodenal passage (B2 and RYGB)– Lowered plasma glucose and insulin – Conclusion: Plasma glucose and insulin fall rapidly post-operatively
• antidiabetic medications can be reduced or stopped shortly after gastrointestinal bypass interventions
Rubino F. Bariatric Surgery:effects on glucose homeostasis. Curr. Opin. Clin. Nutr. Metab. Care 9: 497-507Bittner R. Homeostasis of glucose and gastric resection: the influence of food passage through the duodenum Z Gastroenterology 1981; 19: 698-707.Friedman NM et al. The amelioration of diabetes mellitus following subtotal gastrectomy. Surg. Gynecol. Obstetr. 1955; 100:201-204
Rehfeld J, 2004
1967 – Gastric Bypass
DISCOVERY OF GASTROINTESTINAL HORMONES
How Does Bariatric Surgery Effect glucose homeostasis?
1. Intestinal Malabsorption?• Weight loss reduces insulin resistance• Glucose malabsorption reduces stress on islet cells• Fat malabsorption reduces circulating free fatty acids and
improves insulin sensitivity
2. Hormonal Changes?Re-routing of food alters the dynamic of gut-hormone secretion• Increased levels of glucagon-like peptide 1 (GLP-1)• Decrease in plasma levels of leptin & Grhelin• Increased levels of adiponectin & peptide YY3-36
3. Rearrangement of GI anatomy?• “Hindgut hypothesis”• “Foregut hypothesis”
1. Pathophysiology
Excess adipose tissue increasesavailable triglyceride stores
Breakdown of TG leads to overabundanceof circulating fatty acids
INCREASED FATTY ACIDS
INSULIN RESISTANCEINCREASES HEPATIC TRIGLYCERIDE SYNTHESIS & PRODUCTION OF VLDL
LOSS OF VASODILATORY EFFECT OF INSULIN
PRESERVED SODIUM REABSORPTION
HYPERCHOLESTEROLEMIA
HYPERTENSION
DIABETES
OBESITY
2. Hormonal Changes after Bariatric Surgery
GIP and GLP-1GIP and GLP-1
• Stimulated by enteral nutrients
• insulin secretion / action
-cell proliferation
3. Anti-Incretin Theory3. Anti-Incretin Theory
• Stimulated by enteral nutrients
• insulin secretion / action
-cell proliferation
Anti-incretinAnti-incretin
Hypothesis
Rubino et al; Ann. Surg. 2002
Anti-Incretin
Insulin resistanceBeta cell depletionHyperglycemia
Insulin resistanceBeta cell depletionHyperglycemia
Too MuchToo Much
Dumping Syndrome
NesidioblastosisHyperinsulinemiaHypoglycemia
Dumping Syndrome
NesidioblastosisHyperinsulinemiaHypoglycemia
Not EnoughNot Enough
TYPE 2 DIABETESTYPE 2 DIABETESTYPE 2 DIABETESTYPE 2 DIABETES
Hypothesis
Rubino et al; Ann. Surg. 2002
Slides taken from:Slides taken from:
DIABETES IS NO LONGER A DIABETES IS NO LONGER A HOPELESS DISEASEHOPELESS DISEASE
The Guilty GutThe Guilty Gut
Walter Pories, MD, FACS, Walter Pories, MD, FACS,
Chief, Metabolic Institute Chief, Metabolic Institute
East Carolina University Greenville,East Carolina University Greenville,
North CarolinaNorth Carolina
2006:
Slides taken from:Slides taken from:
DIABETES IS NO LONGER A DIABETES IS NO LONGER A HOPELESS DISEASEHOPELESS DISEASE
The Guilty GutThe Guilty Gut
Walter Pories, MD, FACS, Walter Pories, MD, FACS,
Chief, Metabolic Institute Chief, Metabolic Institute
East Carolina University Greenville,East Carolina University Greenville,
North CarolinaNorth Carolina
2006:
2006:
“This study shows that bypassing a short segment of proximal intestine directly ameliorates type 2 diabetes,
independently of effects on food intake, body weight, malabsorption, or nutrient delivery to the hindgut.”
The Mechanism of Diabetes Control After Gastrointestinal Bypass Surgery Reveals a Role of the Proximal Small Intestine in the Pathophysiology of Type 2 Diabetes. Rubino, Francesco, MD; Forgione, Antonello, MD; Cummings, David E MD; Vix, Michel MD; Gnuli, Donatella MD; Mingrone, Geltrude MD; Castagneto, Marco, MD (S); Marescaux, Jacques MD, FRCS Annals of Surgery; 244 (5): 741-749, November 2006
• Bariatric Surgery clearly has an antidiabetic effect
• Direct effect of the surgical bypass of proximal intestines
• Hormonal Regulation of Glucose Metabolism
• Insulin, glucagons-like peptide (GLP-1), glucose-dependent insulinotropic peptide (GIP), glucagon and leptin
Pacheco D, et al. The effects of duodenal-jejunal exclusion on hormonal regulation of glucose metabolism in Goto-Kakizaki rats. Am J Surgery; 194 (2007): 221-224
2007: Pacheco Bypass & Glucose Metabolism
Animal Model of DJ Bypass and Glycemic Control
• Animal Model of non-obese type 2 diabetes; Goto-Kakizaki rats• Twelve (12-14 wk old) rats randomly underwent gastrojejeunal bypass or no intervention * All fed with same type of diet * All fed with same amount of diet * Pre-op, post-op 1 wk & 1 month weight assessment & fasting glycemia * Oral Glucose Tolerance Test performed at each time point * Hormone levels were measured after 20 minutes of oral overload
Pacheco D, et al. The effects of duodenal-jejunal exclusion on hormonal regulation of glucose metabolism in Goto-Kakizaki rats. Am J Surgery; 194 (2007):221-224
2007- Results of DJ Bypass on Glycemic Control
• Group 1 and Group 2 rats remained the same weight during the experiment
• OGTT improved in DJ bypass group• Glucose levels were better at 1 week & 1
month after DJ bypass in all times of OGTT (basal, 10 min, 120 min)
• Post-oral glucose load levels of glucagon, insulin, GLP-1 and GIP remained unchanged in both groups
• In DJ bypass group there is a significant decrease in leptin levels noted
Pacheco D, et al. The effects of duodenal-jejunal exclusion on hormonal regulation of glucose metabolism in Goto-Kakizaki rats. Am J Surgery; 194 (2007): 221-224Pacheco D, et al. The effects of duodenal-jejunal exclusion on hormonal regulation of glucose metabolism in Goto-Kakizaki rats. Am J Surgery; 194 (2007): 221-224
Leptin???
• Adipocyte-derived hormone
• In mice, leptin acts as a hormonal signal on the afferent limb of a negative feedback loop between the adipose tissue and hypothalmic centers
• Physiological increase in plasma leptin has been shown to significantly inhibit glucose-stimulated insulin secretion in vivo and to determine insulin resistance
Pacheco D, et al. The effects of duodenal-jejunal exclusion on hormonal regulation of glucose metabolism in Goto-Kakizaki rats. Am J Surgery; 194 (2007): 221-224
Cohen -SAGES 2008
PT
Pre-op1yr Pre-op 1YR preop 1yr pre-op 1yr pre-op 3 months
1 8 11.6 256 315 180 164 58 87 <0.5 1.2
2 7 8.5 180 123 157 132 88 84 1.2 1.13 12 7.5 252 90 160 141 70 98 2.5 2.1
4 11 7.7 195 84 158 151 97 109 1.8 0.55 7 6.3 112 63 179 271 44 276 1.3 0.5
6 9 8.6 181 110 227 211 195 119 <0.5 <0.5.7 12 8.9 286 299 225 232 235 118 1.8 2.6
C-PeptideHBA1C FBG Chol TG
Cohen -SAGES 2008
Cohen -SAGES 2008
•Double blind study: 16 patients assigned to LRYGBP and 16 Pts to LSG
•Patients reevaluated on the 1st, 3rd, 6th, and 12th mos
•Results: • No change in ghrelin levels after LRYGBP Significant decrease in ghrelin after LSG (P < 0.0001)
• Fasting PYY levels increased after either surgical procedure (P <= 0.001)
•Appetite decreased in both groups but to a greater extend after LSG
Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy:
a prospective, double blind study.Karamanakos et al Ann Surg. 2008 Mar; 247(3): 401-7.
“PYY levels increased similarly after either procedure. The markedly reduced ghrelin levels in addition to increased PYY levels after LSG, are associated with greater appetitesuppression and excess weight loss compared with LRYGBP”
March 2008: Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study. Karamanakos et al Ann Surg. 2008 Mar;247(3): 401-7.
March 2008:March 2008:
Vidal et al. Type 2 Diabetes Mellitus and the Metabolic Syndrome Following Sleeve Gastrectomy in Severely Obese Subjects. Obes. Surg. June 2008
• 12 mos prospective study 9 severely obese T2DM patients LSG (SG; n = 39) or LRYGP (GBP; n = 52)
• Matched for DM duration, type of DM treatment, and glycemic control
• Results–T2DM resolved 84.6% SG and (84.6%) GBP (p = 0.618)• Shorter DM duration and DM treatment and glycemic
control associated with both groups
• SG is as effective as GBP in inducing remission of T2DM and the MS.
• SG and GBP represent a successful an integrated strategy for the management of the different cardiovascular risk components of the MS in subjects with T2DM
Type 2 Diabetes Mellitus and the Metabolic Syndrome Following Sleeve Gastrectomy in Severely ObeseSubjects. Obes. Surg. 2008, Vidal et al
June 2008
Non-Obese Patients
Slides taken from: Slides taken from: DIABETES IS NO LONGER A HOPELESS DISEASE The Guilty Gut,Walter Pories, MD, FACSDIABETES IS NO LONGER A HOPELESS DISEASE The Guilty Gut,Walter Pories, MD, FACS
• First Clinical description of laparoscopic stomach-preserving DJB for treatment of T2DM in non-obese
• 2 patients with >12 mos f/u (13/15 mos)• By 5th week of surgery, both patients were euglycemic and free of all
antidiabetic medications• Conclusion:
– LDJB is a feasible and safe – could represent valuable therapeutic option
39 patients underwent laparoscopic ileal interposition into proximal jejunum via sleeve or diverted sleeve gastrectomy
BMI < 35All had type II DM for at least 3 yearsMean post-op follow up was 7 monthsMean operative time was 185 minutes
87% of patients discontinued preop oral hypoglycemics, insulin or both
Hemoglobin A1c decreased from 8.8% to 6.3%
All but one patient experienced normalization of cholesterol
DePaula AL. et al. Laparoscopic treatment of type 2 DM for patients with BMI less than 35. Surg. Endosc.
DePaula AL. et al. Laparoscopic treatment of type 2 DM for patients with BMI less than 35. Surg. Endosc.
• Conclusion: – Laparoscopic ileal interposition
via either a sleeve gastrectomy or diverted sleeve gastrectomy seems to be a promising procedure for the control of T2DM and the metabolic syndrome
CLINICAL TRIAL: Duodenal-Jejeunal Bypassfor Type 2 Diabetes (DJBD)
SUMMARY:Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes
FACILITY: Center for Advanced MedicineSanto Domingo, Dominican Republic
STUDY OFFICIALS/INVESTIGATORS:George Ferzli, MD, FACS - Study Principal Investigator, SUNY Downstate, Brooklyn, New York, USA
Abel Gonzalez, MD - Center for Advanced Medicine, Santo Domingo, Dominican Republic
Martin Bluth, MD, PhD - Director of Research, Assistant Professor,Departments of Surgery and Pathology, Brooklyn, NY USA)
Dominican Republic 2007
• Prospective controlled clinical trial
• Seeking to recruit total of 50 patients
• www.clinicaltrials.gov
• Unique Protocol ID: AS07006
• Clinicaltrials.gov ID: NCT00487526.
Lutheran Medical CenterClinical Trial 2008
• Prospective study
• Seeking to recruit total of 50 patients
• www.clinicaltrials.gov
• ID: NCT00694278, LMC 95
Clinical Trial EligibilityInclusion Criteria
• Adults age 20-65 • Clinical diagnosis of type II diabetes:
– a) A normal or high C-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
– b) A random plasma glucose of 200mg/dl or more with typical symptoms of diabetes
– c)A fasting plasma glucose of 126mg/dl or more on more than one occasion
• BMI 22-34 KG/m2, • Patients on oral hypoglycemic medications or insulin to control T2DM
Inadequate control of diabetes as defined as HbA1c>7.5• No contraindications for surgery or general anesthesia• Ability to understand and describe the mechanism of action and risks and
benefits of the operation
Clinical Trial EligibilityExclusion Criteria
• Diagnosis of type 1 diabetes• Planned pregnancy within 2 years of entry into the study• Previous gastric or esophageal surgery, immunosuppressive drugs
including corticosteroids, coagulopathy, anemia, any contraindication to laparoscopic gastric bypass or medical hypoglycemic therapy
• Severe concurrent illness likely to limit life (e.g. cancer) or requiring extensive disorder (e.g. pancreatic insufficiency, Celiac sprue, or Crohn’s disease)
• Pre-existing major complications of diabetes, significant proteinuria (>250mg/dl), severe proliferate retinopathy, severe neuropathy or clinical diagnosis of gastroperesis
• MI in the previous year• Unable to comply with study requirements, follow-up or give verbal
consent• Liver cirrhosis • Previous abdominal surgery (those that involve the stomach and proximal
bowel).
Preoperative work up
• Detailed informed consent explain to patient.• Baseline assessment by multidisciplinary surgical
team – Surgeon, primary physician, endocrinologist, cardiologist, gastroenterologist,
psychiatrist, nutritionist
• Routine work-up and blood work– (CBC, electrolytes, serum creatinine, fasting glucose, HbA1c, fasting lipid profile
(HDL and LDL cholesterol, triglycerides), free fatty acids, leptin, insulin like growth factor 1 (ILGF-1), Glucagon, Glucagon-like peptide 1 (GLP-1), CCK, FFA, Cholesterol, Ghrelin, C-peptide and Gastro-inhibitory peptide (GIP) levels. )
• Studies– Electrocardiogram (ECG), chest radiograph, and Esophagogastroduodenoscopy
(EGD), PFT’S (if indicated)
Operative Course
• Laparoscopic Duodenal-Jejunal bypass under GETA • Preoperative prophylaxis antibiotic (Ancef or Clinda in PCN
allergy) • Sequential compression devices for deep venous thrombosis
(DVT) prophylaxis in addition to LMWH (5,000units SQ). • Operative/Intra-operative data
– OR time, EBL, complications, unusual findings • NPO until upper gastrointestinal (UGI) on POD#1• Clear fluids are begun following the UGI study, and continue for
5-7 days • Patient follow up with nutritionist for dietary guidelines
Postoperative follow up
• Follow up with multidisciplinary team– Surgeon, endocrinologist, primary care physician
and nutritionist at 2 weeks, 4 weeks, 3 months, and from then on at intervals of 3 months or more often if necessary, for 2 years
• Blood drawn for fasting glucose and fasting insulin on days 2 and 7 and at 2 weeks and 4 weeks and 3 months after initiation of treatment
• Nutritionist follow up – continue to puree diet• Attend support group
Outcomes/Measures
• The primary outcome– Reversion of hyperglycemia to euglycemia
(normalization of HbA1c to <7%)
• Secondary outcomes - lipid profiles, and C-peptide
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes (June 2007)
Results
• LDJB was performed successfully in 7 patients
• Mean age of 43.3 range (33-52)
• Limb was 75cm/75cm
• Operative time average 98 min
• Length of stay 3 days
Clinical Evaluation of the Effect of Duodenal -Jejunal Bypass on Type 2 Diabetes (June 2007)
Patient Demographic, June 6, 2007Patient Demographic, June 6, 2007
Morbidity
• Initial symptoms included nausea and vomiting– resolved in all patients by 3 months post-operatively
• One patient developed a liver abscess– required drainage unrelated to the procedure
• No deaths
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes (June 2007)
Results
• HBA1c, Fasting Blood Glucose (FBG), Triglycerides (TG), Cholesterol (Chol) and C-peptide (Cpep) were measured at pre-op and 1 year
• The mean HBA1c at pre-op and 1 year was 9.371 and 8.500 respectively
• FBG at pre-op and 1 year were 208 and 154 respectively for the seven patients (p=0.057)
• Lipid profiles improved with lower total cholesterol levels and
triglycerides 1 year
Data Results
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes ( June 2007)
Clinical Evaluation of the Effect of Duodenal-Jejunal
Bypass on Type 2 Diabetes (June 2007) Table 2
N Correlation Sig.
HBA1c Pre-op & HBA1c 1yr 7 -0.040 0.933
FBG Pre-op & FBG 1YR 7 0.74 0.057
Chol preop & Chol 1yr 7
0.6320.128
TG pre-op & TG 1yr 7
-0.2450.596
Cpep pre-op & Cpep 3 months 7 0.546 0.205
!!!
• One patient required insulin preop, at 6 months she was no longer on insulin and all lab work was normal
• She became pregnant at 6 months following surgery
• Her diabetes returned and her insulin requirement is at the pre-op level
• It is unclear whether she had resolution of her T2DM or had developed gestational diabetes requiring insulin for her pregnancy at the 1-year follow-up
!!!
Our Study- 1 year follow-up5 patients (71%) T2DM > 10 years (10-19)
1 pre oral/insulin-free from medication at 1 yr
2 required less dosages
The remaining two diabetic patients with a clinical diagnosis greater than ten years still require their insulin and oral hypoglycemics.
All 5 patients –no symptoms and improved state of health
!!!
• 2 patients with c-peptide <1, the HbA1c increased following the procedure
SAGES 2008
• 35 patients T2DM for 2-10 years l underwent LDJB• April-Nov 07• 15 women, 20 men• Comorbidities
– 75% with HTN– 58% Hypercholesteremia– 62.5% Hypertriglyceremia
• Mean OR time = 46 minutes (33-78 min)• Hospital stay 30 hrs –81 days• PPI for 90 days• Patients kept on metformin/glimeperide (metformin withdrawn when
HBA1c <6)
Complications
• 1 death
• 2 intestinal obstruction
• 1 pos-operative pancreatitis
• 2 intracavitary bleeding
Results
• HbA1c decreasing from 8.9 to 6.1.
• 72.3% of patients had control of their hypertension: reduced sympathetic outflow?
• 13/35 patients reported food intolerance: 8/13 required admission
(no women)
• Oral Ginger and sildenafil are very helpful
• 75% complained of post-prandial sleepiness– These side effects may be attributed to gastroparesis and the
postulated diminished sympathetic outflow, a result of central leptin suppression and duodenal bypass
Interim Conclusions
Very promising initial experience.
The vast majority of insulin users do not use it anymore very early in the post-op.
In most of those patients with overweight or grade 1 obesity, weight loss is not a major player regarding the control of T2DM, as some had no weight modification or regained weight and there was no recurrence.
Interim Conclusions
What are the correct inclusion/exclusion criteria? Should we cut off at 8, 9, 10 years?
Time of T2DM history does not seem important, but C peptide below 1 YES!!!
Interim Conclusions
Don’t rush to withdraw medication.
We add an incretin effect, but METFORMIN helps to decrease hepatic defective glucose production.
What is the antidiabetes mechanism?
Interim Conclusions
What are the appropriate limb lengths? 50/75/80?
Is it necessary to bypass the entire duodenum? If yes, how can we assess that? Does it make any difference?
Do we need complex operations in this subset of patients? Are the mortality/ complication rates reasonable?
Will an added sleeve gastrectomy in selected patients be needed to avoid gastroparesis, mainly in those with BMI>32? Or is a LRYGB more adequate?
The Surgeon and the Diabetologists
Acknowledgements
• Kell Juliard
• Martin Bluth, MD, PhD
• Giancarlo Cires, MD
• Rosemarie E Hardin, MD
• Joel Ricci, MD