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Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass at 5 years (YOMEGA): a prospective, open-label, non-inferiority, randomised extension study.
Robert, M, Poghosyan, T, Maucort-Boulch, D, Filippello, A, Caiazzo, R, Sterkers, A, Khamphommala, L, Reche, F, Malherbe, V, Torcivia, A, et al
The lancet. Diabetes & endocrinology. 2024;(4):267-276
Abstract
BACKGROUND The multicentre randomised trial YOMEGA (NCT02139813) comparing the one anastomosis gastric bypass (OAGB) with the Roux-en-Y gastric bypass (RYGB) confirmed the non-inferiority of OAGB on weight loss outcomes at 24 months. We aimed to report weight loss, metabolic, and safety outcomes at 5 years. METHODS YOMEGA is a prospective, open-label, non-inferiority, randomised trial conducted at nine centres in France. Inclusion criteria were BMI of 40 kg/m2 or more, or 35 kg/m2 or more with comorbidities. Key exclusion criteria were severe gastro-oesophageal reflux disease or Barrett's oesophagus and previous bariatric surgery. Patients were randomly assigned (1 :1) to OAGB (one gastrojejunal anastomosis with a 200 cm biliopancreatic limb) or RYGB (with a 150 cm alimentary limb and a 50 cm biliary limb), stratified by centre, with blocks of variable size. The primary endpoint of this extension study was percentage excess BMI loss and was analysed in the per-protocol population, including patients with data who were operated on with the technique randomly assigned to them and excluding patients with major deviations from the protocol during the follow-up (change of surgical technique, death, or withdrawal of consent). Non-inferiority was concluded for the primary endpoint if the upper bound of the CI was less than the non-inferiority limit (7 percentage points). YOMEGA is registered with ClinicalTrials.gov, NCT02139813, and the 5-year follow-up of YOMEGA is registered with ClinicalTrials.gov, NCT05549271. FINDINGS Between May 13, 2014, and March 2, 2016, 253 patients were randomly assigned to OAGB (n=129) or RYGB (n=124), and from these patients 114 in the OAGB group and 118 in the RYGB group were included in the per-protocol analysis. In the per-protocol population, at baseline, mean age was 43·0 years (SD 10·8), mean BMI was 44·0 kg/m2 (5·6), 54 (23%) patients were male and 178 (77%) were female; 55 (27%) of 207 patients had type 2 diabetes. After 5 years, mean percentage excess BMI loss was -75·6% (SD 28·1) in the OAGB group versus -71·4% (SD 29·8) in the RYGB group, confirming non-inferiority (mean difference -4·1% [90% CI -12·0 to 3·7], p=0·0099). Remission of type 2 diabetes was similar in both groups. Nutritional status did not differ; the most common adverse event was clinical gastro-oesophageal reflux disease, occurring in 27 (41%) of 66 patients in the OAGB group versus 14 (18%) of 76 patients in the RYGB group (p=0·0030). Among serious adverse events, ten (8%) of 127 patients converted from OAGB to RYGB. 171 (68%) of 253 patients were followed up. INTERPRETATION OAGB was not inferior to RYGB regarding percentage excess BMI loss at 5 years with similar metabolic outcomes. The high rate of clinical gastro-oesophageal reflux disease after OAGB raises questions about its long-term consequences, which need to be further investigated. FUNDING Medtronic.
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2.
Out-of-Pocket Expenses in Households of People Living with Obesity in France.
Fabron, C, Laville, M, Aron-Wisnewsky, J, Disse, E, Gatta-Cherifi, B, Jacobi, D, Montastier, E, Oppert, JM, Gaillard, L, Detournay, B, et al
Obesity facts. 2023;(6):606-613
Abstract
BACKGROUND/OBJECTIVES Overweight and obesity result in a substantial economic burden in both low- and high-income countries. Moreover, this burden is often underestimated because it only partially accounts for unreimbursed out-of-pocket expenses (OOPE) related to obesity. The objective of our study was not only to evaluate OOPE incurred by people with obesity in relation to their disease with respect to direct medical expenditures and direct non-medical expenditures but also the proportion of people living with obesity who have forgone obesity-related healthcare due to the costs of such care. METHODS An observational descriptive survey was conducted among people with class II/III obesity attending six obesity treatment centers in France. Volunteer adult participants completed a written/phone questionnaire on their related expenditures over the last 6 months for current expenditures and over the last 5 years for occasional ones. The costs were expressed in 2022 EUR. RESULTS 299 people participated (age: 46 years [SD: 13.9], women: 72%, BMI ≥40 kg/m2: 62% and 48% with comorbidities). 65% had a professional activity. 83% declared that they had OOPE related to obesity representing annually EUR 2027/individual on average (5% of the household revenue), including weight loss and nutritional products, vitamins, meal programs, gym memberships, psychologists, but mainly adapted clothing, additional travel costs, and others. 15% of the respondents had to modify their professional activity due to obesity and 15% forwent some medical care in the last 12 months. CONCLUSIONS OOPE is a significant part of the economic burden of obesity. Despite some limitations due to the specificities of the participants and because some costs may be more related to social activities affected by obesity than to healthcare, it seems important to consider these expenditures in cost estimates for obesity.
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Polyphenol Supplementation Did Not Affect Insulin Sensitivity and Fat Deposition During One-Month Overfeeding in Randomized Placebo-Controlled Trials in Men and in Women.
Segrestin, B, Delage, P, Nemeth, A, Seyssel, K, Disse, E, Nazare, JA, Lambert-Porcheron, S, Meiller, L, Sauvinet, V, Chanon, S, et al
Frontiers in nutrition. 2022;:854255
Abstract
Two randomized placebo-controlled double-blind paralleled trials (42 men in Lyon, 19 women in Lausanne) were designed to test 2 g/day of a grape polyphenol extract during 31 days of high calorie-high fructose overfeeding. Hyperinsulinemic-euglycemic clamps and test meals with [1,1,1-13C3]-triolein were performed before and at the end of the intervention. Changes in body composition were assessed by dual-energy X-ray absorptiometry (DEXA). Fat volumes of the abdominal region and liver fat content were determined in men only, using 3D-magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) at 3T. Adipocyte's size was measured in subcutaneous fat biopsies. Bodyweight and fat mass increased during overfeeding, in men and in women. While whole body insulin sensitivity did not change, homeostasis model assessment of insulin resistance (HOMA-IR) and the hepatic insulin resistance index (HIR) increased during overfeeding. Liver fat increased in men. However, grape polyphenol supplementation did not modify the metabolic and anthropometric parameters or counteract the changes during overfeeding, neither in men nor in women. Polyphenol intake was associated with a reduction in adipocyte size in women femoral fat. Grape polyphenol supplementation did not counteract the moderated metabolic alterations induced by one month of high calorie-high fructose overfeeding in men and women. The clinical trials are registered under the numbers NCT02145780 and NCT02225457 at ClinicalTrials.gov and available at https://clinicaltrials.gov/ct2/show/NCT02145780 and https://clinicaltrials.gov/ct2/show/NCT02225457.
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Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study.
Breyton, AE, Goux, A, Lambert-Porcheron, S, Meynier, A, Sothier, M, VanDenBerghe, L, Brack, O, Disse, E, Laville, M, Vinoy, S, et al
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2021;(1):237-246
Abstract
BACKGROUND AND AIMS In type 2 diabetes (T2D) patients, the reduction of glycemic variability and postprandial glucose excursions is essential to limit diabetes complications, beyond HbA1c level. This study aimed at determining whether increasing the content of Slowly Digestible Starch (SDS) in T2D patients' diet could reduce postprandial hyperglycemia and glycemic variability compared with a conventional low-SDS diet. METHODS AND RESULTS For this randomized cross-over pilot study, 8 subjects with T2D consumed a controlled diet for one week, containing starchy products high or low in SDS. Glycemic variability parameters were evaluated using a Continuous Glucose Monitoring System. Glycemic variability was significantly lower during High-SDS diet compared to Low-SDS diet for MAGE (Mean Amplitude of Glycemic Excursions, p < 0.01), SD (Standard Deviation, p < 0.05), and CV (Coefficient of Variation, p < 0.01). The TIR (Time In Range) [140-180 mg/dL[ was significantly higher during High-SDS diet (p < 0.0001) whereas TIRs ≥180 mg/dL were significantly lower during High-SDS diet. Post-meals tAUC (total Area Under the Curve) were significantly lower during High-SDS diet. CONCLUSION One week of High-SDS Diet in T2D patients significantly improves glycemic variability and reduces postprandial glycemic excursions. Modulation of starch digestibility in the diet could be used as a simple nutritional tool in T2D patients to improve daily glycemic control. REGISTRATION NUMBER in clinicaltrials.gov: NCT03289494.
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A systematic review and meta-analyses of food preference modifications after bariatric surgery.
Guyot, E, Dougkas, A, Nazare, JA, Bagot, S, Disse, E, Iceta, S
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2021;(10):e13315
Abstract
This systematic review and meta-analyses aimed to synthesize evidence of the link between bariatric surgery and changes in food preferences, considering the method of assessment. MEDLINE, Cochrane Library, Web of Science, Cinahl, PsychINFO, ProQuest, and Open grey were searched incorporating two blocks of terms ("Intervention" and "Food Preferences"). Interventional or observational studies involving patients (BMI ≥ 35 kg m-2 ) with sleeve gastrectomy (SG) or Roux-en-Y Gastric Bypass (RYGB) and a control group were included. Meta-analyses were performed comparing the standardized daily mean percentage energy from proteins, carbohydrates, and lipids between preoperative and postoperative patients. Fifty-seven studies concerning 2,271 patients with RYGB and 903 patients with SG met the inclusion criteria, of which 24 were eligible for meta-analysis. Despite a total reduction in macronutrient intakes, the meta-analyses revealed a postoperative increase in percentage energy from proteins at 12 months (0.24, 95% CI: 0.03, 0.46, {I2 } = 73%) and a decrease in percentage energy from fat at 1 month (-0.47, 95% CI: 0.86, 0.09, {I2 } = 72%), up to 24 months (-0.20, 95% CI: -0.31, 0.08, {I2 } = 0%). In conclusion, the present systematic review and meta-analyses showed changes of food preferences in terms of macronutrient, food selection and, overall food appreciation up to 5 years following bariatric surgery.
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6.
Bariatric surgery affects obesity-related protein requirements.
Guillet, C, Masgrau, A, Mishellany-Dutour, A, Blot, A, Caille, A, Lyon, N, Pereira, B, Slim, K, Robert, M, Disse, E, et al
Clinical nutrition ESPEN. 2020;:392-400
Abstract
CONTEXT Following bariatric surgery, protein deficiency intakes are reported in morbidly obese patients, whereas post-bariatric protein requirements are not specifically defined with validated method in this population. OBJECTIVE To assess average protein requirement (APR) in obese subjects, before, 3 months and 12 months after bariatric surgery using the validated method of nitrogen balance. DESIGN AND SETTING Prospective longitudinal study conducted in 21 morbidly obese patients (BMI 43.9 ± 1.4 kg/m2) before (M0), 3 months (M3) and 12 months (M12) after sleeve gastrectomy or Roux-en-Y gastric by-pass. An additional larger cross-sectional study was performed to validate APR before surgery in non-operated matched obese patients (n = 106). APR was evaluated at M0, M3, M12 by measuring 3 days dietary intakes together with losses of nitrogen in urine and stools. MAIN OUTCOME MEASURE APR was defined as the mean value of protein intake required to achieve balance nitrogen equilibrium. RESULTS Before surgery, APR in morbidly obese patients was 0.76 [95%CI, 0.66-0.92] g/kg Body Weight (BW)/d in the experimental group, and 0.74 [0.70-0.80] g/kg BW/d in the validation group. APR was 0.62 [0.51-0.75] g/kg/d at M3 and 0.87 [0.75-0.98] g/kg/d at M12, with no difference between surgical procedures. Spontaneous protein intakes were respectively 0.80 ± 0.05, 0.43 ± 0.03 and 0.71 ± 0.04 g/kg BW/d respectively at M0, M3 and M12. CONCLUSION This study demonstrates a temporal change in protein requirement after bariatric surgery whatever the type of surgery. Spontaneous protein intakes following bariatric surgery does not cover protein requirements for most patients, suggesting that specific dietary protein recommandations have to be adapted in obese patients with bariatric surgery. TRIAL REGISTRATION Clinicaltrials.gov Identifier: NCT01249326.
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Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study.
Cariou, B, Hadjadj, S, Wargny, M, Pichelin, M, Al-Salameh, A, Allix, I, Amadou, C, Arnault, G, Baudoux, F, Bauduceau, B, et al
Diabetologia. 2020;63(8):1500-1515
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People with diabetes have an increased risk for infections, especially influenza and pneumonia, and also appear to be particularly vulnerable to develop severe disease or die from Covid-19. The aim of this multicentre observational study from France was to determine clinical and biological features in patients with diabetes and hospitalised for Covid-19. A total of 1317 patients were analysed, with the main outcomes being intubation for mechanical ventilation (reached by 267 patients, 29%) or death (140 patients, 10.6%) within 7 days of being admitted to hospital. HbA1C, as a marker of how well controlled the diabetes was, was not associated with either risk of death or need for mechanical ventilation. When other factors were taken into account, only body mass index was associated with risk of ventilation, whilst age, history of microvascular or macrovascular complications (injury to small or large blood vessels), and treated obstructive sleep apnoea were found to be independently associated with the risk of death. Of clinical and blood test parameters on admission, difficulty breathing, lymphopaenia (low levels of specific white blood cells), and increased AST (marker of liver function) and CRP (marker of inflammation) were independent factors for predicting severity of the course of COVID-19.
Abstract
AIMS/HYPOTHESIS Coronavirus disease-2019 (COVID-19) is a life-threatening infection caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus. Diabetes has rapidly emerged as a major comorbidity for COVID-19 severity. However, the phenotypic characteristics of diabetes in COVID-19 patients are unknown. METHODS We conducted a nationwide multicentre observational study in people with diabetes hospitalised for COVID-19 in 53 French centres in the period 10-31 March 2020. The primary outcome combined tracheal intubation for mechanical ventilation and/or death within 7 days of admission. Age- and sex-adjusted multivariable logistic regressions were performed to assess the prognostic value of clinical and biological features with the endpoint. ORs are reported for a 1 SD increase after standardisation. RESULTS The current analysis focused on 1317 participants: 64.9% men, mean age 69.8 ± 13.0 years, median BMI 28.4 (25th-75th percentile: 25.0-32.7) kg/m2; with a predominance of type 2 diabetes (88.5%). Microvascular and macrovascular diabetic complications were found in 46.8% and 40.8% of cases, respectively. The primary outcome was encountered in 29.0% (95% CI 26.6, 31.5) of participants, while 10.6% (9.0, 12.4) died and 18.0% (16.0, 20.2) were discharged on day 7. In univariate analysis, characteristics prior to admission significantly associated with the primary outcome were sex, BMI and previous treatment with renin-angiotensin-aldosterone system (RAAS) blockers, but not age, type of diabetes, HbA1c, diabetic complications or glucose-lowering therapies. In multivariable analyses with covariates prior to admission, only BMI remained positively associated with the primary outcome (OR 1.28 [1.10, 1.47]). On admission, dyspnoea (OR 2.10 [1.31, 3.35]), as well as lymphocyte count (OR 0.67 [0.50, 0.88]), C-reactive protein (OR 1.93 [1.43, 2.59]) and AST (OR 2.23 [1.70, 2.93]) levels were independent predictors of the primary outcome. Finally, age (OR 2.48 [1.74, 3.53]), treated obstructive sleep apnoea (OR 2.80 [1.46, 5.38]), and microvascular (OR 2.14 [1.16, 3.94]) and macrovascular complications (OR 2.54 [1.44, 4.50]) were independently associated with the risk of death on day 7. CONCLUSIONS/INTERPRETATIONS In people with diabetes hospitalised for COVID-19, BMI, but not long-term glucose control, was positively and independently associated with tracheal intubation and/or death within 7 days. TRIAL REGISTRATION clinicaltrials.gov NCT04324736.
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Obesity is Associated with Severe Forms of COVID-19.
Caussy, C, Wallet, F, Laville, M, Disse, E
Obesity (Silver Spring, Md.). 2020;28(7):1175
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One of the emerging findings of the COVID-19 pandemic is a prevalence of obesity and the severity of SARS-Cov-2 suffered by patients. Findings from this French seminal study reports a higher number of invasive mechanical ventilation in patients at Lille hospital with severe obesity (28.2%) with a BMI ≥35 kg/m2 versus lean patients < 25 kg/m2. At the time of print there were still 37% of these obese patients in ICU, in need of longer treatment than lean patients. Data from a Lyon hospital showed a lower number of obesity patients admitted into ICU at 11.3%, however this correlates with geographical differences in obesity levels. There were also differences in the medical approach between hospitals with Lyon favouring high-flow oxygen therapy through a nasal cannula with only the most severe patients mechanically ventilated. The differences in therapy raises the question whether patients with severe obesity (BMI ≥35 kg/m2) would benefit from an earlier intervention using invasive mechanical ventilation to help reduce the overall time spent in ICU.
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Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol.
Robert, M, Poghosyan, T, Delaunay, D, Pelascini, E, Iceta, S, Sterkers, A, Barsamian, C, Khamphommala, L, Bin Dorel, S, Maucort-Boulch, D, et al
BMJ open. 2020;(9):e037576
Abstract
INTRODUCTION Despite the non-negligible weight loss failure rate at midterm, Roux-en-Y gastric bypass (RYGB) remains the reference procedure in the treatment of morbid obesity with metabolic comorbidities. A recently emerged procedure, the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), could be more effective on weight loss with similar morbidity and lower weight loss failure rate than RYGB. We propose the first randomised, open, multicentre superiority trial comparing the SADI-S to RYGB (SADISLEEVE). METHODS AND ANALYSIS The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 with at least one comorbid condition and candidate to a first bariatric procedure or after failure of sleeve gastrectomy. Patients randomised by minimisation in two arms, based on centre, surgery as a revisional procedure, presence of type 2 diabetes and BMI >50 kg/m2 will be included over 2 years.A sample size of 166 patients in each group will have a power of 90% to detect a probability of 0.603 that excess weight loss in the RYGB arm is less than excess weight loss in the SADI-S arm with a 5% two-sided significance level. With a drop-out rate of 10%, it will be necessary to include 183 patients per group. ETHICS AND DISSEMINATION The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER NCT03610256.
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[Thyroid dysfunctions secondary to cancer immunotherapy].
Cugnet Anceau, C, Abeillon, J, Maillet, D, Borson-Chazot, F, Disse, E
Bulletin du cancer. 2020;(2):262-271
Abstract
The immune checkpoint inhibitors (CPI) such as anti-PD(L)1 or anti-CTLA4 had improved long-term patients' outcomes in different malignancies. Thyroid disorders are the most frequent endocrine side effects from CPI reported in clinical trials and in clinical routine practice. The incidence of thyroid dysfunction is variable according to ICP used (more frequent under anti-programmed cell death 1 (PD1) or anti-programmed cell death-ligand 1 (PDL1)). Most thyroid dysfunctions have been reported to occur 2 to 4 courses after CPI initiation. The clinical symptoms are generally nonspecific (asthenia, weight change, rarely cardiac rhythm disorder). These thyroid dysfunctions are commonly painless thyroiditis with a biphasic evolution: thyrotoxicosis followed by a secondary hypothyroidism frequently definitive. Diagnosis is made on a thyroid test (TSH and FT4). In most cases, no further exam is necessary. Beta blockers therapy is recommended in symptomatic thyrotoxicosis with palpitations. Thyroid hormones therapy will be introduced quickly in case of hypothyroidism. Thyroid dysfunctions are not a contra-indication to the continuation of immunotherapy. Due to the high frequency of these complications, close monitoring of the thyroid status is recommended under CPI.