Stacy A. Brethauer

Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes

BACKGROUND Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery. METHODS In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. RESULTS Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications. CONCLUSIONS In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).

Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient—2013 update: Cosponsored by american association of clinical endocrinologists, The obesity society, and american society for metabolic & bariatric surgery*

The development of these updated guidelines was commissioned by the AACE, TOS, and ASMBS Board of Directors and adheres to the AACE 2010 protocol for standardized production of clinical practice guidelines (CPG). Each recommendation was re‐evaluated and updated based on the evidence and subjective factors per protocol. Examples of expanded topics in this update include: the roles of sleeve gastrectomy, bariatric surgery in patients with type‐2 diabetes, bariatric surgery for patients with mild obesity, copper deficiency, informed consent, and behavioral issues. There are 74 recommendations (of which 56 are revised and 2 are new) in this 2013 update, compared with 164 original recommendations in 2008. There are 403 citations, of which 33 (8.2%) are EL 1, 131 (32.5%) are EL 2, 170 (42.2%) are EL 3, and 69 (17.1%) are EL 4. There is a relatively high proportion (40.4%) of strong (EL 1 and 2) studies, compared with only 16.5% in the 2008 AACE‐TOS‐ASMBS CPG. These updated guidelines reflect recent additions to the evidence base. Bariatric surgery remains a safe and effective intervention for select patients with obesity. A team approach to perioperative care is mandatory with special attention to nutritional and metabolic issues.

Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 3-Year Outcomes

BACKGROUND Long‐term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. METHODS We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body‐mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux‐en‐Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. RESULTS Of the 150 patients who underwent randomization, 1 patient died during the 5‐year follow‐up period; 134 of the remaining 149 patients (90%) completed 5 years of follow‐up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention‐to‐treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention‐to‐treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric‐bypass and sleeve‐gastrectomy groups were superior to the changes seen in the medical‐therapy group with respect to body weight (‐23%, ‐19%, and ‐5% in the gastric‐bypass, sleeve‐gastrectomy, and medical‐therapy groups, respectively), triglyceride level (‐40%, ‐29%, and ‐8%), high‐density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (‐35%, ‐34%, and ‐13%), and quality‐of‐life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36‐Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. CONCLUSIONS Five‐year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo‐Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.)

Systematic review of sleeve gastrectomy as staging and primary bariatric procedure

d ( p u c p w l c w p Sleeve gastrectomy (SG) is gaining popularity worldide as a bariatric procedure both as a first-stage procedure n high-risk or super obese patients and as a primary opertion. The potential advantages of the SG are that it confers mmediate restriction of caloric intake, does not require lacement of a foreign body or require adjustments, and can enerally be performed in less time than required for bypass rocedures. The possible disadvantages of the SG include he irreversibility, increased operative risk compared with ther restrictive procedures, and unproved durability. The urpose of the present systematic review was to evaluate the urrent evidence regarding weight loss, complication rates, ostoperative mortality, and co-morbidity improvement afer SG.

Can Diabetes Be Surgically Cured?: Long-Term Metabolic Effects of Bariatric Surgery in Obese Patients with Type 2 Diabetes Mellitus

Objective: Evaluate the long-term effects of bariatric surgery on type 2 diabetes (T2DM) remission and metabolic risk factors. Background: Although the impressive antidiabetic effects of bariatric surgery have been shown in short- and medium-term studies, the durability of these effects is uncertain. Specifically, long-term remission rates following bariatric surgery are largely unknown. Methods: Clinical outcomes of 217 patients with T2DM who underwent bariatric surgery between 2004 and 2007 and had at least 5-year follow-up were assessed. Complete remission was defined as glycated hemoglobin (A1C) less than 6% and fasting blood glucose (FBG) less than 100 mg/dL off diabetic medications. Changes in other metabolic comorbidities, including hypertension, dyslipidemia, and diabetic nephropathy, were assessed. Results: At a median follow-up of 6 years (range: 5–9) after surgery (Roux-en-Y gastric bypass, n = 162; gastric banding, n = 32; sleeve gastrectomy, n = 23), a mean excess weight loss (EWL) of 55% was associated with mean reductions in A1C from 7.5% ± 1.5% to 6.5% ± 1.2% (P < 0.001) and FBG from 155.9 ± 59.5 mg/dL to 114.8 ± 40.2 mg/dL (P < 0.001). Long-term complete and partial remission rates were 24% and 26%, respectively, whereas 34% improved (>1% decrease in A1C without remission) from baseline and 16% remained unchanged. Shorter duration of T2DM (P < 0.001) and higher long-term EWL (P = 0.006) predicted long-term remission. Recurrence of T2DM after initial remission occurred in 19% and was associated with longer duration of T2DM (P = 0.03), less EWL (P = 0.02), and weight regain (P = 0.015). Long-term control rates of low high-density lipoprotein, high low-density lipoprotein, high triglyceridemia, and hypertension were 73%, 72%, 80%, and 62%, respectively. Diabetic nephropathy regressed (53%) or stabilized (47%). Conclusions: Bariatric surgery can induce a significant and sustainable remission and improvement of T2DM and other metabolic risk factors in severely obese patients. Surgical intervention within 5 years of diagnosis is associated with a high rate of long-term remission.

Acute effects of gastric bypass versus gastric restrictive surgery on β-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes

Context:Hyperglycemia resolves quickly after bariatric surgery, but the underlying mechanism and the most effective type of surgery remains unclear.Objective:To examine glucose metabolism and β-cell function in patients with type 2 diabetes mellitus (T2DM) after two types of bariatric intervention; Roux-en-Y gastric bypass (RYGB) and gastric restrictive (GR) surgery.Design:Prospective, nonrandomized, repeated-measures, 4-week, longitudinal clinical trial.Patients:In all, 16 T2DM patients (9 males and 7 females, 52±14 years, 47±9 kg m−2, HbA1c 7.2±1.1%) undergoing either RYGB (N=9) or GR (N=7) surgery.Outcome measures:Glucose, insulin secretion, insulin sensitivity at baseline, and 1 and 4 weeks post-surgery, using hyperglycemic clamps and C-peptide modeling kinetics; glucose, insulin secretion and gut-peptide responses to mixed meal tolerance test (MMTT) at baseline and 4 weeks post-surgery.Results:At 1 week post-surgery, both groups experienced a similar weight loss and reduction in fasting glucose (P<0.01). However, insulin sensitivity increased only after RYGB, (P<0.05). At 4 weeks post-surgery, weight loss remained similar for both groups, but fasting glucose was normalized only after RYGB (95±3 mg 100 ml−1). Insulin sensitivity improved after RYGB (P<0.01) and did not change with GR, whereas the disposition index remained unchanged after RYGB and increased 30% after GR (P=0.10). The MMTT elicited a robust increase in insulin secretion, glucagon-like peptide-1 (GLP-1) levels and β-cell sensitivity to glucose only after RYGB (P<0.05).Conclusion:RYGB provides a more rapid improvement in glucose regulation compared with GR. This improvement is accompanied by enhanced insulin sensitivity and β-cell responsiveness to glucose, in part because of an incretin effect.

Metabolic Effects of Bariatric Surgery in Patients With Moderate Obesity and Type 2 Diabetes: Analysis of a randomized control trial comparing surgery with intensive medical treatment

OBJECTIVE To evaluate the effects of two bariatric procedures versus intensive medical therapy (IMT) on β-cell function and body composition. RESEARCH DESIGN AND METHODS This was a prospective, randomized, controlled trial of 60 subjects with uncontrolled type 2 diabetes (HbA1c 9.7 ± 1%) and moderate obesity (BMI 36 ± 2 kg/m2) randomized to IMT alone, IMT plus Roux-en-Y gastric bypass, or IMT plus sleeve gastrectomy. Assessment of β-cell function (mixed-meal tolerance testing) and body composition was performed at baseline and 12 and 24 months. RESULTS Glycemic control improved in all three groups at 24 months (N = 54), with a mean HbA1c of 6.7 ± 1.2% for gastric bypass, 7.1 ± 0.8% for sleeve gastrectomy, and 8.4 ± 2.3% for IMT (P < 0.05 for each surgical group versus IMT). Reduction in body fat was similar for both surgery groups, with greater absolute reduction in truncal fat in gastric bypass versus sleeve gastrectomy (−16 vs. −10%; P = 0.04). Insulin sensitivity increased significantly from baseline in gastric bypass (2.7-fold; P = 0.004) and did not change in sleeve gastrectomy or IMT. β-Cell function (oral disposition index) increased 5.8-fold in gastric bypass from baseline, was markedly greater than IMT (P = 0.001), and was not different between sleeve gastrectomy versus IMT (P = 0.30). At 24 months, β-cell function inversely correlated with truncal fat and prandial free fatty acid levels. CONCLUSIONS Bariatric surgery provides durable glycemic control compared with intensive medical therapy at 2 years. Despite similar weight loss as sleeve gastrectomy, gastric bypass uniquely restores pancreatic β-cell function and reduces truncal fat, thus reversing the core defects in diabetes.

Laparoscopic sleeve gastrectomy for super obese patients: forty-eight percent excess weight loss after 6 to 8 years with 93% follow-up.

Objectives:In this study, we report long-term outcomes of high-risk, high-BMI (body mass index) patients who underwent laparoscopic sleeve gastrectomy (LSG). Background:Short- and medium-term data appear to support the effectiveness of LSG, but long-term data to support its durability are sparse. Methods:A prospective database was reviewed on all high-risk patients who underwent LSG as part of a staged approach for surgical treatment of severe obesity between January 2002 and February 2004. We included only patients who did not proceed to second-stage surgery (gastric bypass). Analyzed data included demographics, BMI, comorbidities, and surgical outcomes. All partial gastrectomies were performed using a 50F bougie. Results:Seventy-four patients underwent LSG, and follow-up data were available on 69 of 74 patients (93%). The mean age was 50 years (25–78) and the mean number of co-morbidities was 9.6. Perioperative mortality (<30 days) was zero, and the incidence of short- and long-term postoperative complications was 15%. The mean overall follow-up time period was 73 months (38–95). Mean excess weight loss (EWL) at 72, 84, and 96 months after LSG was 52%, 43%, and 46%, respectively, with an overall EWL of 48%. The mean BMI decreased from 66 kg/m2(43–90) to 46 kg/m2 (22–73). Seventy-seven percent of the diabetic patients showed improvement or remission of the disease. Conclusions:This study reports the longest follow-up of LSG patients thus far and supports the effectiveness, safety, and durability of laparoscopic sleeve gastrectomy as a definitive therapeutic option for severe obesity, even in high-risk, high-BMI patients.

Pure Natural Orifice Translumenal Endoscopic Surgery (NOTES) Transvaginal Nephrectomy

Natural orifice translumenal endoscopic surgery (NOTES) within urology has largely been limited to experimental animal studies and diagnostic procedures in humans. Attempts to complete a pure NOTES transvaginal nephrectomy have thus far been unsuccessful. We report the first clinical experience with pure NOTES transvaginal nephrectomy. A 58-year-old woman presented with recurrent urinary tract infections and an atrophic right kidney. Transvaginal access was obtained through a 3-cm posterior colpotomy. The right kidney was mobilized, the renal hilum was divided, and the specimen was removed through the vaginal incision. Operative time was 420 min. Estimated blood loss was 50 ml. There were no perioperative complications.

Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force.

BACKGROUND Reoperative bariatric surgery has become a common practice in many bariatric surgery programs. There is currently little evidence-based guidance regarding specific indications and outcomes for reoperative bariatric surgery. A task force was convened to review the current evidence regarding reoperative bariatric surgery. The aim of the review was to identify procedure-specific indications and outcomes for reoperative procedures. METHODS Literature search was conducted to identify studies reporting indications for and outcomes after reoperative bariatric surgery. Specifically, operations to treat complications, failed weight loss, and weight regain were evaluated. Abstract and manuscript reviews were completed by the task force members to identify, grade, and categorize relevant studies. RESULTS A total of 819 articles were identified in the initial search. After review for inclusion criteria and data quality, 175 articles were included in the systematic review and analysis. The majority of published studies are single center retrospective reviews. The evidence supporting reoperative surgery for acute and chronic complications is described. The evidence regarding reoperative surgery for failed weight loss and weight regain generally demonstrates improved weight loss and co-morbidity reduction after reintervention. Procedure-specific outcomes are described. Complication rates are generally reported to be higher after reoperative surgery compared to primary surgery. CONCLUSION The indications and outcomes for reoperative bariatric surgery are procedure-specific but the current evidence does support additional treatment for persistent obesity, co-morbid disease, and complications.