Sleeve gastrectomy and Roux-en-Y gastric bypass in the treatment of type 2 diabetes. Two-year results from a Swedish multicenter randomized controlled trial

doi:10.1016/j.soard.2020.04.033

Surgery for Obesity and Related Diseases

Volume 16, Issue 8, August 2020, Pages 1035-1044

https://doi.org/10.1016/j.soard.2020.04.033 Get rights and content

Abstract

Background

Obesity is a world-wide epidemic and it is a risk factor for type 2 diabetes (T2D). Few randomized controlled studies have compared the 2 most common surgical procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in the treatment of obese patients with T2D.

Objectives

To compare diabetes remission rates (glycosylated hemoglobin ≤6.0%, without diabetes medications) in obese T2D patients (body mass index, 35–50) undergoing RYGB or SG.

Setting

Three University Hospital clinics and 1 Regional Hospital in Sweden.

Methods

Forty-nine patients with T2D were included. Twenty-five were randomized to RYGB and 24 to SG. There was no difference between groups regarding patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels. All patients (100%) completed 1-year follow-up and 47 (95.9%) 2-year follow-up.

Results

Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up. Similarly, mean glycosylated hemoglobin was improved in both groups at 1 and 2 years, with no significant differences between the groups (RYGB baseline versus 1 yr; mean ± standard deviation: 7.9 ± 1.5 versus 5.8 ± .6%, P < .0001; versus 2 yr: 5.9 ± .7%, P < .0001; SG baseline versus 1 yr: 8.2 ± 1.9 versus 5.9 ± .7%, P < .0001; versus 2 yr: 5.9 ± 1.1%, P < .0001). Total weight loss was not different but percentage excess weight loss was higher after RYGB compared with SG both at 1 and 2 years; mean ± standard deviation: 78 ± 22 versus 60 ± 22%, and 76 ± 24 versus 54 ± 21%, respectively (P < .01 for both). Waist circumference also decreased significantly more in the RYGB group.

Conclusions

Despite superior excess weight loss after RYGB, T2D remission rates did not differ significantly between RYGB and SG after 2 years. Long-term follow-up data are needed to define the role of SG in the treatment of patients with obesity and T2D.

Section snippets

Methods

Patients referred for bariatric surgery were considered for participation in the study. Inclusion criteria were T2D requiring antidiabetic medications, BMI between 35 and 50 kg/m², and age between 18 and 60 years. Patients were excluded if they had uncontrolled psychiatric disorder, alcohol and/or substance abuse, severe nephropathy (chronic kidney disease index >2), retinopathy or neuropathy, had previously undergone surgical weight reducing procedures, or if Barrett’s esophagus was diagnosed

Results

There were no differences at baseline between the groups regarding age, sex, BMI, waist circumference, diabetes duration, and co-morbidities (Table 1). All patients had urine samples examined for proteinuria. There were 8 (32%) patients with microalbuminuria in the RYGB group and 6 (25%) patients in the SG group (P = .592). The average operation time was similar for RYGB and SG, 93.9 ± 37.1 and 91.8 ± 47.7 minutes, respectively (P = .865). One patient (4.2%) in the SG group and 3 patients (12%)

Discussion

In the present study, similar T2D remission rates were found at 2 years after RYGB and SG. Our data corroborate the findings in some other randomized controlled studies comparing the outcomes after RYGB and SG in patients with T2D [[16], [17], [18], [19]]. However, the reported remission rates vary between studies. One year after surgery, the T2D remission rates in the study by Murphy et al. [17] were comparable to our present data showing 52% and 49% remission rates with no medications in RYGB

Conclusions

In this randomized study, T2D remission rates did not differ significantly between RYGB and SG at the 2-year follow-up. However, larger studies with long-term follow-up data are needed to define the role of SG in the treatment of patients with obesity and T2D.

Disclosures

The authors have no commercial associations that might be a conflict of interest in relation to this article.

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Cited by (23)

Comparison of various prediction models in the effect of Roux-en-Y gastric bypass on type 2 diabetes in the Chinese population 5 years after surgery
2023, Surgery for Obesity and Related Diseases
Various prediction models of type 2 diabetes (T2D) remission have been externally verified internationally. However, long-term validated results after Roux-en-Y gastric bypass (RYGB) surgery are lacking. The best model for the Chinese population is also unknown.
To evaluate the prediction effect of various prediction models on the long-term diabetes remission after RYGB in the Chinese population and to provide reference for clinical use.
A retrospective clinical study at a university hospital.
We retrospectively analyzed Chinese population data 5 years after RYGB and externally validated 11 predictive models to evaluate the predictive effect of each model on long-term T2D remission after RYGB.
We enrolled 84 patients. The mean body mass index was 41 kg/m², and the percentage of excess weight loss (%EWL) was 72.3%. The mean glycated hemoglobin level was 8.4% preoperatively and decreased to 5.9% after 5 years. The 5-year postoperative complete and partial remission rates of T2D were 31% and 70.2%, respectively. The ABCD scoring model (sensitivity, 84%; specificity, 76%; area under the curve [AUC], .866) and the Panuzi et al. [34] study (sensitivity, 84%; specificity, 81%; AUC, .842) showed excellent results. In the Hosmer-Lemeshow goodness-of-fit test, calibration values for ABCD and Panuzi et al. [34] were .14 and .21, respectively. The predicted-to-observed ratios of ABCD and Panuzi et al. [34] were .83 and .88, respectively.
T2D was relieved to varying degrees 5 years after RYGB in patients with obesity. The prediction models in ABCD and the Panuzi et al. [34] studies showed the best prediction effects. ABCD was recommended for clinical use because of excellent predictive performance, good statistical test results, and simple and practical design features.
Resolution of diabetes, gastrointestinal symptoms, and self-reported dietary intake after gastric bypass versus sleeve gastrectomy: a randomized study
2023, Surgery for Obesity and Related Diseases
There is a lack of randomized studies examining diabetes remission and dietary intake between patients undergoing Roux-en-Y gastric bypass (RYGB) versus sleeve gastrectomy (SG).
To examine longitudinal differences in diabetes resolution, dietary intake, and gastrointestinal (GI) symptoms in patients with obesity and type 2 diabetes (T2D) randomized to either RYGB or SG and according to remission of T2D.
Four hospitals in Sweden, 2 of which are university hospitals.
Dietary intake and GI symptoms were calculated from questionnaires and morphometric differences between surgical methods and T2D remission were compared using the Student t test, effect size (ES) for parametric parameters, and Mann-Whitney U test for nonparametric parameters.
Five years after RYGB or SG there was no significant difference in the rate of remission of T2D between RYGB and SG (43% versus 20%, P = .176). RYGB (n = 19) patients had greater weight loss than SG patients (n = 14) (26.4 [9.5] versus 13.1 [9.6] kg, P < .001), despite reporting higher daily caloric intake (Δ 669 kcal, P = .059, ES .67) and food weight (Δ 1029 g/d, P = .003, ES 1.11). RYGB patients, compared with SG patients, also ate 1 more fruit per day (P = .023). Pooled data showed no differences between patients with and without T2D remission regarding weight loss, but those in remission drank more nonalcoholic drinks and milk.
Five years postoperatively, patients randomized to RYGB reported considerably higher food intake compared with SG despite lower body weight. The reason and importance of the higher food intake after RYGB compared with SG needs to be further studied.
Genetic reprogramming of rHemnant duodenum may contribute to type 2 diabetes improvement after Roux-en-Y gastric bypass
2022, Nutrition
Type 2 diabetes control occurs within a few days after Roux-en-Y gastric bypass (RYGB) and might be related to intestinal adaptation to the new anatomic arrangement. The aim of this study was to evaluate the intestinal transcriptome response to RYGB and its correlation with markers of glycemic homeostasis.
Global transcriptomic analyses performed by microarray technique were conducted in intestinal biopsies collected from adult women with obesity (N = 20) and T2D before and 3 mo after RYGB. Clinical and biochemical markers of glycemic homeostasis were also evaluated. At 1-y postoperative, patients were classified as responsive (R) or non-responsive (NR) to complete T2D remission according to the American Diabetes Association criteria. Intestinal differentially expressed genes (DEGs) were analyzed separately in the two groups, validated by reverse transcription quantitative polymerase chain reaction, and applied in functional enrichment and canonical pathway analysis. Spearman correlations between clinical and biochemical variables with DEGs were conducted. Twelve patients were classified as R and displayed 62 (duodenum), 241 (jejunum), and 63 (ileum) DEGs.
Eight of the patients with DEGs presented very strong or strong positive correlations with glycemia or glycated hemoglobin. Duodenal changes of genes involved in the LXR/RXR pathway were more likely to be associated with T2D.
In obese women, complete remission of T2D after RYGB might include intestinal transcriptomic changes that suggest a potential role of intracellular cholesterol and lipid homeostasis on glucose control.
Time impact on the antidiabetic effects of key bariatric surgeries: a network meta-analysis of randomized controlled trials with meta-regression
2022, Surgery for Obesity and Related Diseases
Few studies compare the efficacy of the key bariatric procedures in type 2 diabetes management over the long term. None offer a reliable comparison of their respective efficacy loss over time.
To analyze and compare the time evolution of the antidiabetic effects of the key bariatric procedures.
Obesity surgery departments in America, Europe, and Asia.
All the randomized clinical trials assessing the efficacy of bariatric surgery in type 2 diabetes management with 1–5 years of follow-up were reviewed. A network meta-analysis with meta-regression was performed to compare the effectiveness of each technique and its respective efficacy loss temporal dynamics.
Thirty-one trials involving 1906 patients were included. In comparison to Roux-en-Y gastric bypass, the 5-year complete or partial diabetes remission rates were inferior with medical treatment (odds ratio [OR] = .05; 95% credible interval [CrI]: .02–.13) and gastric banding (OR = .38; 95% CrI: .16–.87), equivalent with sleeve gastrectomy (OR = 1.08; 95% CrI: .59–1.97), and superior with 1 anastomosis gastric bypass (OR = 3.00; 95% CrI: 1.12–8.33) and biliopancreatic diversion and its affiliated techniques (OR = 3.71; 95% CrI: 1.16–12.55). However, remission rates and glycemic control progressively decreased whatever the treatment option evaluated. Moreover, this loss of efficacy followed a statistically comparable temporal dynamic to those of Roux-en-Y gastric bypass regardless of the therapeutic strategy implemented.
No therapeutic modality offered stable antidiabetic effects. The gap observed between the techniques after a 5-year follow up concerning remission rates and glycemic control could depend essentially on the magnitude of the effects initially obtained. However, these results need to be confirmed over longer follow-up periods.
The clinical outcomes, appetite and metabolic effects of sleeve gastrectomy and Roux-en-Y gastric bypass: A comparative review
2022, Current Opinion in Endocrine and Metabolic Research
Bariatric surgery is a highly effective treatment for obesity, leading to sustained weight loss and improvements in obesity-related comorbidities. Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the commonest bariatric procedures performed. These procedures lead to weight loss via increasing satiety and altering food preferences, rather than restriction and malabsorption. RYGB and SG result in markedly different postoperative anatomy and thus may have differential effects on the gut–brain axis. This review aims to compare the postoperative clinical outcomes and changes in appetite following RYGB and SG. We review evidence for the mechanisms underlying each procedure, including changes to gut hormone signalling, bile acids, vagal signalling, and the gut microbiome. We also highlight areas of controversy that require further study.
Assurance of surgical quality within multicenter randomized controlled trials for bariatric and metabolic surgery: a systematic review
2022, Surgery for Obesity and Related Diseases
Surgical quality assurance methods aim to ensure standardization and high quality of surgical techniques within multicenter randomized controlled trials (RCTs), thereby diminishing the heterogeneity of surgery and reducing biases due to surgical variation. This study aimed to establish the measures undertaken to ensure surgical quality within multicenter RCTs investigating bariatric and metabolic surgery, and their influence upon clinical outcomes.
An electronic literature search was performed from the Embase, Medline, and Web of Science databases to identify multicenter RCTs investigating bariatric and metabolic surgery. Each RCT was evaluated against a checklist of surgical quality measures within 3 domain: (1) standardization of surgical techniques; (2) credentialing of surgical experience; and (3) monitoring of performance. Outcome measures were postoperative weight change and complications.
Nineteen multicenter RCTs were included in the analysis. Three studies undertook pretrial education of surgical standard. Fourteen studies described complete standardization of surgical techniques. Four studies credentialed surgeons by case volume prior to enrollment. Two studies used intraoperative or video evaluation of surgical technique prior to enrollment. Only two studies monitored performance during the study. Although there were limited quality assurance methods undertaken, utilization of these techniques was associated with reduced overall complications. Standardization of surgery was associated with reduced re-operation rates but did not influence postoperative weight loss.
The utilization of methods for surgical quality assurance are very limited within multicenter RCTs of bariatric and metabolic surgery. Future studies must implement surgical quality assurance methods to reduce variability of surgical performance and potential bias within RCTs.

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: VW reports grants from the Region Västra Götaland in Sweden (grant no. ALFGBG 813871) and grants from Erik and Lily Philipson memorial foundation. AT reports grants from the Erling-Persson Family Foundation (grant no. 140604). AM reports grants from the Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland in Sweden (grant no. VGFOUREG-384231).

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Original article: surgerySleeve gastrectomy and Roux-en-Y gastric bypass in the treatment of type 2 diabetes. Two-year results from a Swedish multicenter randomized controlled trial

Abstract

Background

Objectives

Setting

Methods

Results

Conclusions

Section snippets

Methods

Results

Discussion

Conclusions

Disclosures

Surg Obes Relat Dis

BMC Surg

Surg Obes Relat Dis

Surg Obes Relat Dis

Surgery

The long-term effects of bariatric surgery on type 2 diabetes remission, microvascular and macrovascular complications, and mortality: a systematic review and meta-analysis

Obes Surg

Bariatric surgery: a systematic review and meta-analysis

JAMA

Meta-analysis: surgical treatment of obesity

Ann Intern Med

Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery

N Engl J Med

IFSO Worldwide survey 2016: primary, endoluminal, and revisional procedures

Obes Surg

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

Ann Surg

Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial

Ann Surg

Glycemic control after sleeve gastrectomy and Roux-en-Y gastric bypass in obese subjects with type 2 diabetes mellitus

Obes Surg

Diabetes improvement and resolution following laparoscopic vertical sleeve gastrectomy (LVSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures: a systematic review of randomized controlled trials

Surg Endosc

Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial

Arch Surg

Original article: surgery
Sleeve gastrectomy and Roux-en-Y gastric bypass in the treatment of type 2 diabetes. Two-year results from a Swedish multicenter randomized controlled trial