Baseline neutrophil-to-lymphocyte ratio is associated with long-term T2D remission after metabolic surgery.

AIMS: Metabolic surgery is considered as a therapeutic option for obese patients with type 2 diabetes (T2D). In order to identify novel laboratory variables that could improve the selection of patients who might greatly benefit from a surgical approach, we focused on the neutrophil-to-lymphocyte ratio (NLR) as a predictor of long-term T2D remission following metabolic surgery. METHODS: Thirty-one obese patients with T2D included in this pilot study underwent Roux-en-Y gastric bypass or biliopancreatic diversion (BPD) at the Surgical Department of Genoa University, IRCCS Ospedale Policlinico San Martino in Genoa (Italy). Before surgery, serum samples were collected to evaluate blood count, glycemic profile, and circulating neutrophil degranulation products. RESULTS: The median age was 56 years, median body mass index (BMI) was 32.37 kg/m2, and median glycated hemoglobin was 8.4%. White blood cell count was in a range of normality, with a median NLR of 1.97. By a receiver operating characteristic curve analysis, NLR has been found to be significantly associated with T2D remission at 1, 3, and 5 years and the best cutoff of ≤ 1.97 has been identified by Youden index. When comparing study groups according to NLR cutoff, those with NLR ≤ 1.97 were older and underwent more often BPD. By a logistic regression analysis, NLR ≤ 1.97 has been found to predict T2D remission across 5 years, irrespective of baseline BMI. CONCLUSIONS: A baseline low NLR is associated with long-term T2D remission in obese patients undergoing metabolic surgery, suggesting that circulating inflammatory cells (i.e., neutrophils) might negatively impact on T2D remission.

Type 2 Diabetes Remission and Control in Overweight and in Mildly Obese Diabetic Patients at Long-Term Follow-Up After Biliopancreatic Diversion.

BACKGROUND: In severely obese patients with type 2 diabetes (T2DM), the metabolic benefits after biliopancreatic diversion (BPD) are due to mechanisms independent of weight loss. Therefore, the anti-diabetic effect of BPD in overweight or mildly obese T2DM patients was investigated. METHODS: Ninety T2DM patients with BMI 25-35 underwent BPD and were evaluated 1 and 5 years after the operation (follow-up rate 100 and 83%, respectively). RESULTS: T2DM control (Hb1Ac < 7%) and remission (Hb1Ac < 6 without antidiabetics) was observed in 86.6 and 65% of cases at 1 year and 64.0% and 26.5% at 5 years, respectively. The long-term T2DM remission was predicted by baseline BMI value. Both before BPD and throughout the follow-up period, HOMA values were similar in the metabolically successful and unsuccessful subjects, while C-peptide normalized for FBG value as a marker of beta cell mass and insulin secretion increased progressively only in the former from 1.06 ± 0.64 to 1.44 ± 1.08 mcg/l ml/dl-1 * 100 (p < 0.002). CONCLUSIONS: In T2DM patients with BMI of 25-35, a positive metabolic outcome is less frequent than in their counterparts with morbid obesity. In T2DM overweight patients, in spite of a short-term normalization of FBG and HbA1c levels and a well-sustained increase of insulin sensitivity, a long-term T2DM relapse occurs in the majority of the cases. While the surgically obtained decrease in insulin resistance leads to T2DM control in half of the patients, the increase in insulin secretion is mandatory for T2DM stable remission.

Long-Term Follow-Up Study of Liver-Related Outcome After Bilio-Pancreatic Diversion in Patients with Initial, Significant Liver Damage.

BACKGROUND: Obesity is associated with NAFLD, and bariatric surgery has significant impact on this liver disease, with reported improvement in hepatic fibrosis. AIMS: To investigate the effects of bariatric surgery on long-term liver disease-related outcome in obese patients with nonalcoholic fatty liver disease (NAFLD) and significant liver damage. METHODS: This study included 56 NAFLD patients who underwent bilio-pancreatic diversion for morbid obesity and who had significant fibrosis at intraoperative liver biopsy. Data were analyzed at 1, 3, and 5 years of follow-up, and at the latest available visit in patients who had longer follow-up. We assessed the incidence of clinically relevant liver events (ascites, hepatic encephalopathy, portal hypertension-related bleeding, and jaundice) as well as modifications of a validated biochemical index such as the NAFLD score. RESULTS: During a median follow-up of 78 months, median weight decreased from 119 to 78 kg (P < 0.0001), and median body mass index decreased from 45.2 to 29.0 kg/m2 (P < 0.0001). None of the patients developed clinical complications of liver disease, and none died due to liver-related causes. Median NAFLD score significantly decreased (P = 0.0005) during follow-up from - 0.929 (- 1.543 to - 0.561) to - 1.609 (- 2.056 to - 1.102). The NAFLD score category was unchanged in 32 patients (57%), improved in 18 (32%), and worsened in 6 (11%). CONCLUSIONS: Patients with NAFLD and proven histological liver damage at surgery do not develop complications of liver disease in long term after bilio-pancreatic diversion. Moreover, noninvasive parameters of liver damage improve. Thus, preexisting liver damage does not seem to be a contraindication to bilio-pancreatic diversion.

Management of malabsorptive bariatric surgery after cancer surgery for malignancies of the digestive apparatus.

BACKGROUND: Data regarding management of former bariatric operations after onset of a malignancy are still lacking and there is no consensus whether bariatric surgery negatively influences the oncologic management of patients. OBJECTIVES: To investigate the strategy by which patients previously submitted to bariatric surgery were managed after diagnosis of malignancy of the digestive apparatus, whether a revision was performed or not, to assess the incidence of nutritional complications, and the effect of revision versus no revision of bariatric surgery on the outcome of cancer treatment. SETTING: University Hospital, Italy. METHODS: Occurrence of a malignancy of the digestive apparatus in patients submitted to biliopancreatic diversion was investigated retrospectively. Patients' data were collected preoperatively, at 2 and 3 years after the operation, at oncologic diagnosis, and at the longest available postoncologic follow-up. RESULTS: From May 1976 to January 2017, 3341 morbidly obese patients were submitted to biliopancreatic diversion. Sixteen patients were diagnosed with a malignancy involving the digestive apparatus 5 to 28 years after bariatric surgery. Of 10 patients diagnosed with colorectal cancer, 6 were revised. At 2 years after biliopancreatic diversion, body mass index, hemoglobin, and iron levels were significantly lower than preoperatively. Serum transferrin and total protein were unchanged. There was no difference between body mass index, hemoglobin, transferrin, and total protein levels at 2 years and at oncologic diagnosis, or between revised and unrevised patients. CONCLUSION: Revision of a preexisting bariatric operation after digestive cancer surgery is common, although selected, unrevised cases do not seem to be associated with worse outcome.

Early reduction of matrix metalloproteinase-8 serum levels is associated with leptin drop and predicts diabetes remission after bariatric surgery.

BACKGROUND: We aimed at investigating whether the acute abrogation of leptin after bariatric surgery is able to reduce neutrophil activation and potentially affect type 2 diabetes mellitus (T2DM) remission. METHODS: Metabolic and inflammatory parameters (i.e. leptin, IL-6 and neutrophil products) were compared at baseline (before bariatric surgery), one month, one and three years after surgery in morbid obese (MOB) T2DM patients (n=12) and non-MOB controls (n=32). In vitro, the effects of leptin on Il-6-induced human neutrophil degranulation and integrin upregulation were assessed. RESULTS: At baseline, MOB T2DM patients had a similar demographic, lipid and glycemic profiles than non-MOB T2DM controls, but higher levels of inflammatory mediators, such as CRP, fibrinogen, neutrophil-to-lymphocyte ratio (NLR), matrix metalloproteinase (MMP)-8 and leptin. One month after surgery, CRP, fibrinogen and MMP-8 were reduced only in MOB T2DM patients, while serum leptin was reduced in both groups. In the overall cohort, leptin and MMP-8 drops from baseline to one month post-surgery were positively correlated (Δleptin vs. ΔMMP8: r=0.391, p=0.025). Moreover, ΔMMP8 inversely correlated with fasting glucose levels at one-year follow-up and with glycated hemoglobin at both one- and three-year. At the cut-off point identified by ROC curve analysis (>0ng/mL), ΔMMP8 predicted complete T2DM remission at 3-year follow-up. In vitro, leptin increased IL-6-induced MMP-8 release and abrogated CD18 up-regulation. CONCLUSION: Bariatric surgery is associated to an acute abrogation of leptin that could affect MMP-8 levels, particularly in MOB T2DM patients. This beneficial event is associated with T2DM remission at 3-year follow-up.

Prediction of Diabetes Remission at Long Term Following Biliopancreatic Diversion.

IMPORTANCE: In obese patients with type 2 diabetes (T2DM), the marked weight loss following bariatric surgery is accompanied in a consistent number of cases by T2DM resolution or control. The clinical need of preoperative parameters reliable in predicting a positive metabolic outcome at long term following the operation has then emerged. OBSERVATION: A cohort of 135 consecutive T2DM patients with a wide range of body mass index (BMI) at more than 5 years following biliopancreatic diversion (BPD) was considered. The 5-year-T2DM resolution, defined as glycosylated hemoglobin (HbA1C) lower than 6.5% without antidiabetic therapy, was related to demographic, anthropometric, and biochemical findings prior to the operation. The long-term metabolic outcome was positively related to baseline BMI values and negatively with the preoperative use of insulin. CONCLUSION: BMI and insulin therapy at the time of surgery are associated with the probability of T2DM long lasting remission and could be used as solid predictors before surgery. In the overweight and non morbidly obese diabetic patients, bariatric surgery is less efficient in determining long term T2DM resolution than in their morbid obese counterparts.

Adipokine Pattern After Bariatric Surgery: Beyond the Weight Loss.

Besides the role in energy storing and body health isolating, adipose tissue produces proteins, the so-called adipokines, with pro-inflammatory or anti-inflammatory actions that contribute to metabolic control and to appetite and energy expenditure regulation. The marked adipose tissue loss following bariatric surgery corresponds to a rearrangement of serum adipokine pattern, with increase of anti-inflammatory and decrease of pro-inflammatory agents. This might play a relevant role in the postoperative improvement of metabolic conditions. However, after surgically induced weight loss, other investigations failed to evidence significant modifications of serum concentration of some adipokines. This review speculates that the composition of adipose tissue lost could influence postoperative changes in some adipokine concentration and that an adequate adipokine pattern plays a pivotal role for the long-term metabolic outcome.

Serum Leptin and Adiponectin Concentration in Type 2 Diabetes Patients in the Short and Long Term Following Biliopancreatic Diversion.

BACKGROUND: A deranged adipokine system is implicated in obesity and in type 2 diabetes mellitus (T2DM), and the lack of remission of T2DM after bariatric surgery could be also accounted for by the postoperative persistence of this condition. METHODS: Thirty T2DM patients undergoing biliopancreatic diversion (BPD) with a wide range of baseline body mass index (BMI) were evaluated prior to and at 1 and 5 years following BPD. Besides the usual clinical evaluations, acute insulin response (AIR) to intravenous glucose load as a parameter of insulin secretion and the serum leptin and adiponectin concentration were measured throughout the follow-up period in all patients. RESULTS: A long-term T2DM remission was observed in 21 patients (70 %). Serum leptin level reduced at the first year and remained substantially unchanged at a long term in both the remitter and non-remitter patients, while following the operation, a progressive significant increase of serum adiponectin level was observed only in remitter patients (from 9.2 to 12.3 µg/mL at 1 year and to 15.18 µg/mL at 5 years in the remitters and from 8.8 to 8.75 µg/mL at 1 year and to 11.8 µg/mL at 5 years in the non-remitters). Serum leptin mean values were positively associated with the BMI ones both prior to and following BPD (p < 0.005), while serum adiponectin values were positively related (p < 0.04) to the postoperative AIR data. CONCLUSIONS: The improvement of the pattern of cytokine production, as evidenced by postoperative rise in serum adiponectin concentration, might play a role in T2DM remission after bariatric surgery.

Long-term clinical and functional impact of biliopancreatic diversion on type 2 diabetes in morbidly and non-morbidly obese patients.

SETTING: Obesity surgery has been proposed as a treatment option for diabetic patients with body mass index (BMI)<35 kg/m(2), but the efficacy of metabolic surgery has not been conclusively determined. OBJECTIVES: To evaluate the long-term metabolic outcome of non-morbidly obese (NMO) patients with type 2 diabetes (T2D) after biliopancreatic diversion (BPD). MATERIAL AND METHODS: Two groups of T2D patients with different degree of obesity (NMO, 17 cases, BMI 25-35 kg/m(2); and morbidly obese [MO], 13 cases, BMI>35 kg/m(2)) were studied before and at 1 and 5 years after BPD in a university hospital setting. Insulin secretion was assessed by acute insulin response (AIR) to intravenous glucose and by insulinogenic index (IGI). RESULTS: In all MO patients, T2D was remitted or controlled (1 case) at 1 year and results were maintained at 5 years; AIR (µU/mL) and IGI (µU/mg) improved (P<.001) at 1 year (from .1±3.1 to 18.52±21.9, and from 6.0±8.5 to 9.1±22.8, respectively) with a further increase (to 24.8±25.5 and to 14.3±13.8, respectively) at 5 years. Within the NMO group, T2D was remitted in 1/17 and controlled in 14/17 patients at 1 year, and in 2/17 and in 4/17 patients at 5 years, respectively; AIR (µU/mL) and IGI (µU/mg) remained unchanged throughout the postoperative period (from .31±9.26 to 1.5±2.8 at 1 yr and to .4±3.29 at 5 yr for AIR, and from 2.2±4.9 to 1.3±9.0 at 1 yr and to 2.3±3.3 at 5 yr for IGI). CONCLUSIONS: After BPD, restoration of ß-cell secretion/production plays a pivotal role in determining postoperative T2D remission.

The long-term impact of biliopancreatic diversion on glycemic control in the severely obese with type 2 diabetes mellitus in relation to preoperative duration of diabetes.

BACKGROUND: Bariatric surgery has been shown to be effective in severely obese patients with type 2 diabetes mellitus (T2DM). OBJECTIVE: Evaluate the long-term efficacy of biliopancreatic diversion (BPD) for the treatment of T2DM depending on the preoperative duration of T2DM. SETTING: University Hospital. METHODS: Retrospective analysis investigating 2 subsets of severely obese patients who had undergone BPD from 1984 to 1995. The first included 52 patients with a preoperative T2DM duration of ~1 year (SD group - 49 on oral agents and 3 on insulin), and the second included 68 patients who had been diabetic for>5 years before BPD (LD group - 52 on oral agents and 16 on insulin). Postoperatively, T2DM was regarded as in remission when fasting serum glucose (FSG) was lower than 100 mg/dL on regular diet and without antidiabetic therapy. RESULTS: In the SD patients, the number of individuals without T2DM remission were lower both at 5-10 (0/31, 0% of patients, versus 8/54, 15% of patients, p<.04) and at>15 years (1/28, 3% of patients, versus 10/41, 24% of patients, p<.0012). Furthermore, after BPD, the number of patients with dyslipidemia strongly reduced (p<.001) in both groups, values at 5-10 years remaining very similar to those observed at>15 years. CONCLUSION: These results indicate that severely obese patients with longer T2DM duration have a worse metabolic outcome maintained at long and very long term following BPD.

Portomesenteric venous thrombosis: an early postoperative complication after laparoscopic biliopancreatic diversion.

The number of bariatric operations, as well as the incidence of perioperative complications, has risen sharply in the past ten years. Perioperative acute portal vein thrombosis is an infrequent and potentially severe postoperative complication that has not yet been reported after biliopancreatic diversion (BPD). Three cases are presented of portal vein thrombosis that occurred following BPD treatment for morbid obesity and type 2 diabetes. The thromboses were detected by abdominal ultrasound and computed tomography with intravenous contrast. The portomesenteric venous thromboses in all three cases presented as unexpected abdominal pain several days after discharge from the hospital. The complications occurred despite adequate perioperative prophylaxis and progressed to bowel gangrene in the diabetic patients only. These cases demonstrate the occurrence of this rare type of complication, which may be observed by physicians that do not routinely treat bariatric patients. Awareness of this surgical complication will allow for early diagnosis and prompt initiation of adequate therapy.

Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35.

BACKGROUND: This study aims to investigate if the benefits on glycemic control following Roux-en-Y gastric bypass (RYGB) in morbidly obese type 2 diabetes (T2DM) patients are maintained in the 30-35 kg/m(2) BMI (body mass index) range, comparing results with those in literature. METHODS: The study participants were twenty T2DM patients aging 35-70 years, BMI 30.0-34.9 kg/m(2), minimum diabetes duration 3 years, glycosylated haemoglobin (HbA1c) ≥7.5% despite good clinical practice medical therapy, submitted to laparoscopic RYGB, and monitored during 36 months. Twenty-seven matched diabetic patients as controls. RESULTS: Five females, mean age 57 (42-69) years, weight 96.0 (70-111) kg, BMI 32.9 (30.3-34.9) kg/m(2), waist circumference 112 (100-128) cm, diabetes duration 14 (3-28) years, HbA1c 9.5 (7.5-14.2) %, and C-peptide 3.2 (1,6-9.1) mcg/l. Ten patients were on insulin. There was no mortality, and there were two major late complications. BMI and waist decreased stabilizing around 25 kg/m(2) and 92 cm. Fasting serum glucose and HbA1c reached values around 150 mg/dl and 7%, which subsequently maintained. There was remission in 25% of cases, control 45%, and all the others improved. HOMA-IR and insulin sensitivity index normalized at 1 month, then maintained. AIR and insulinogenic index showed no postoperative changes. Diabetes remission correlated negatively with duration (p < 0.05; r (2) = 0.61), while control positively with C-peptide (p < 0.05; r (2) = 0.19). In the control group, FSG, HbA1c, serum triglyceride, and cholesterol significantly decreased with considerable progressive increase of antidiabetic/antihyperlipemic therapy. All patients had HbA1c >7% at 2-3 years. CONCLUSIONS: Glycemic control obtained by RYGB in this study was less good than that reported by others, apparently due to different patient selection criteria. Our results do not support RYGB weight loss-independent effect on beta-cell function in the T2DM patients with BMI 30-35 kg/m(2).

Interdisciplinary European Guidelines on metabolic and bariatric surgery.

In 2012, an outstanding expert panel derived from IFSO-EC (International Federation for the Surgery of Obesity-European Chapter) and EASO (European Association for the Study of Obesity), composed by key representatives of both Societies including past and present presidents together with EASO's OMTF (Obesity Management Task Force) chair, agreed to devote the joint Medico-Surgical Workshop of both institutions to the topic of metabolic surgery as a pre-satellite of the 2013 European Congress on Obesity (ECO) to be held in Liverpool given the extraordinarily advancement made specifically in this field during the past years. It was further agreed to revise and update the 2008 Interdisciplinary European Guidelines on Surgery of Severe Obesity produced in cooperation of both Societies by focusing in particular on the evidence gathered in relation to the effects on diabetes during this lustrum and the subsequent changes that have taken place in patient eligibility criteria. The expert panel composition allowed the coverage of key disciplines in the comprehensive management of obesity and obesity-associated diseases, aimed specifically at updating the clinical guidelines to reflect current knowledge, expertise and evidence-based data on metabolic and bariatric surgery.

Biliopancreatic diversion in nonobese patients with type 2 diabetes: impact and mechanisms.

CONTEXT: Diabetes remission is frequent after biliopancreatic diversion (BPD) in morbidly obese patients with type 2 diabetes (T2D). Data, mechanisms, and clinical indications in nonobese T2D patients are scanty. OBJECTIVE: The objective of the study was to assess remission and investigate insulin sensitivity and ß-cell function after BPD in nonobese patients with long-standing T2D. DESIGN, SETTING, AND PATIENTS: This was a clinical research study comparing 15 T2D patients (aged 55 ± 1 years, duration of 16 ± 2 years, body mass index of 28.3 ± 0.6 kg/m², glycosylated hemoglobin 8.6% ± 1.3%) with 15 gender-, age-, and body mass index-matched nondiabetic controls. Before surgery and 2 months and 1 year later, a 3-hour oral glucose tolerance test, a 5-hour mixed-meal test, and a 3-hour euglycemic clamp were performed. INTERVENTION: The intervention included a BPD (distal gastrectomy, proximal ileum anastomosed to remaining stomach, biliopancreatic limb anastomosed to ileum 50 cm from the ileocecal valve). RESULTS: Glycemia improved in all patients, but remission (glycosylated hemoglobin < 6.5% and normal oral glucose tolerance test) occurred in 6 of 15 patients. Insulin resistance (19.8 ± 0.8 µmol · min⁻¹ · kg(ffm)⁻¹, P < .001 vs 40.9 ± 5.3 of controls) resolved already at 2 months (34.2 ± 2.8) and was sustained at 1 year (34.7 ± 1.6), although insulin-mediated suppression of endogenous glucose production remained impaired. In contrast, ß-cell glucose sensitivity (19 [12] pmol · min⁻¹ · m⁻² · mM⁻¹ vs 96 [73] of controls, P < .0001) rose (P = .02) only to 31 [26] at 1 year and was lower in nonremitters (16 [18]) than remitters (46 [33]). CONCLUSIONS: In nonobese patients with long-standing T2D, BPD improves metabolic control but induces remission in only approximately 40% of patients. Peripheral insulin sensitivity is restored early after surgery and similarly in remitters and nonremitters, indicating a weight-independent effect of the operation. The initial extent of ß-cell incompetence is the main predictor of the metabolic outcome.

Tissue specificity in fasting glucose utilization in slightly obese diabetic patients submitted to bariatric surgery.

OBJECTIVE: The present study was planned to investigate, by means of quantitative FDG-PET, how bariatric surgery (BS) modifies the metabolic pattern of the whole body and different tissues in slightly obese patients with type 2 diabetes mellitus (T2DM). DESIGN AND METHODS: Before, 1 and 4 months after BS, 21 consecutive slightly obese T2DM patients underwent blood sampling to estimate plasma levels of glucose, insulin, glycosylated hemoglobin. At the same time points, these patients underwent a dynamic (18) F-FDG PET study of thorax and upper abdomen in fasting state and after washout of T2DM therapy. Gjedde-Patlak analysis was applied to estimate glucose uptake in the whole body and in different tissues (myocardium, skeletal back muscle, adipose tissue, and liver). RESULTS: Surgical intervention quickly lowered levels of both insulin and glucose documenting an amelioration of glucose tolerance. Similarly, skeletal muscle and myocardial glucose uptake significantly increased soon after surgery (P < 0.001 and P < 0.01 at 1 month versus baseline, respectively) and remained substantially stable thereafter. By contrast, glucose uptake slightly decreased from its baseline values in the liver (P < 0.01 at 4 months) while no response could be documented over time in the adipose tissue. CONCLUSIONS: These findings document that BS-induced modification of glucose homeostasis in slightly obese T2DM patients is mostly due to an increase in muscle glucose consumption. The surgically modified metabolic pattern of these patients might be of interest as a new model to investigate mechanism underlying insulin resistance.

Thirty-five years of biliopancreatic diversion: notes on gastrointestinal physiology to complete the published information useful for a better understanding and clinical use of the operation.

BACKGROUND: In the attempt to complete the available information on biliopancreatic diversion (BPD) use and mechanisms of action, some data and observations are presented that for different reasons were never published before. METHODS: These pieces of information derive from minute efforts of gastrointestinal physiology research or from rigorous but preliminary and incomplete collection of data, combined with the daily input from clinical use of BPD. RESULT: They essentially regard intestinal limbs, gastric volume, and their interactions in affecting energy and protein intestinal absorption in BPD. CONCLUSION: It is hoped that this new information will help surgeons to increase their knowledge and improve their ability to obtain the best results from the BPD procedure.

Can a protocol for glycaemic control improve type 2 diabetes outcomes after gastric bypass?

BACKGROUND: Roux-en-Y gastric bypass surgery (RYGB) is an effective treatment for patients with type 2 diabetes (T2DM). Tight glycaemic control immediately after RYGB for T2DM may improve long-term glycaemic outcomes, but is also associated with a higher risk of hypoglycaemia. We designed a treatment algorithm to achieve optimal glycaemic control in patients with insulin-treated T2DM after RYGB and evaluated its feasibility, safety and efficacy. METHODS: Fifty patients following protocol-driven diabetes management were discharged on a fixed amount of metformin and glargine, with the insulin dose adjusted according to a standardised insulin sliding scale aiming for a fasting capillary glucose (FCG) of 5.5-6.9 mmol/L. Glycaemic outcome and remission of diabetes (defined as HbA1c < 6% and FCG levels < 5.6 mmol/L for at least 1 year without hypoglycaemic medication) were compared between patients who received protocol-driven treatment and a similar cohort of 49 patients following standard glycaemic management. RESULTS: At 1 year follow-up, the protocol-driven group showed a greater improvement in glycaemic control than the non-protocol-driven group (HbA1c -3.0 ± 0.2% vs. -1.2 ± 0.1%, P < 0.001; FCG levels -3.4 ± 0.2 vs. -2.0 ± 0.2 mmol/L, P = 0.02) and a higher remission rate from T2DM (50.0% vs. 6.1%, P < 0.001). No symptomatic hypoglycaemia was reported in either group. CONCLUSIONS: The protocol-driven management proved to be feasible, safe and effective in achieving targeted glycaemic control in T2DM after RYGB. The next step will be to scrutinise the efficacy of protocol-driven management in a randomised controlled clinical trial.