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Patient-reported outcomes, weight loss, and remission of type 2 diabetes 3 years after gastric bypass and sleeve gastrectomy (Oseberg); a single-centre, randomised controlled trial.
Svanevik, M, Lorentzen, J, Borgeraas, H, Sandbu, R, Seip, B, Medhus, AW, Hertel, JK, Kolotkin, RL, Småstuen, MC, Hofsø, D, et al
The lancet. Diabetes & endocrinology. 2023;(8):555-566
Abstract
BACKGROUND Little is known about the comparative effects of various bariatric procedures on patient-reported outcomes. We aimed to compare 3-year effects of gastric bypass and sleeve gastrectomy on patient-reported outcome measures in patients with obesity and type 2 diabetes. METHODS The Oseberg trial was a single-centre, parallel-group, randomised trial at Vestfold Hospital Trust, a public tertiary obesity centre in Tønsberg, Norway. Eligible patients were aged 18 years or older with previously verified BMI 35·0 kg/m2 or greater. Diabetes was diagnosed if glycated haemoglobin was at least 6·5% (48 mmol/mol) or by their use of anti-diabetic medications with glycated haemoglobin at least 6·1% (43 mmol/mol). Eligible patients were randomly assigned (1:1) to gastric bypass or sleeve gastrectomy. All patients received identical preoperative and postoperative treatment. Randomisation was done with a computerised random number generator and a block size of ten. Study personnel, patients, and the primary outcome assessor were blinded to allocations for 1 year. The prespecified secondary outcomes reported here were 3-year changes in several clinically important patient-reported outcomes, weight loss, and diabetes remission. Analyses were done in the intention to treat population. This trial is ongoing, closed to recruitment and is registered with ClinicalTrials.gov, NCT01778738. FINDINGS Between Oct 15, 2012 and Sept 1, 2017, 319 consecutive patients with type 2 diabetes scheduled for bariatric surgery were assessed for eligibility. 101 patients were not eligible (29 did not have type 2 diabetes according to inclusion criteria and 72 other exclusion criteria) and 93 declined to participate. 109 patients were enrolled and randomly assigned to sleeve gastrectomy (n=55) or gastric bypass (n=54). 72 (66%) of 109 patients were female and 37 (34%) were male. 104 (95%) of patients were White. 16 patients were lost to follow up and 93 (85%) patients completed the 3-year follow-up. Three additional patients were contacted by phone for registration of comorbidities Compared with sleeve gastrectomy, gastric bypass was associated with a greater improvement in weight-related quality of life (between group difference 9·4, 95% CI 3·3 to 15·5), less reflux symptoms (0·54, 0·17 to -0·90), greater total bodyweight loss (8% difference, 25% vs 17%), and a higher probability of diabetes remission (67% vs 33%, risk ratio 2·00; 95% CI 1·27 to 3·14). Five patients reported postprandial hypoglycaemia in the third year after gastric bypass versus none after sleeve-gastrectomy (p=0·059). Symptoms of abdominal pain, indigestion, diarrhoea, dumping syndrome, depression, binge eating, and appetitive drive did not differ between groups. INTERPRETATION At 3 years, gastric bypass was superior to sleeve gastrectomy in patients with type 2 diabetes and obesity regarding weight related quality of life, reflux symptoms, weight loss, and remission of diabetes, while symptoms of abdominal pain, indigestion, diarrhoea, dumping, depression and binge eating did not differ between groups. This new patient-reported knowledge can be used in the shared decision-making process to inform patients about similarities and differences between expected outcomes after the two surgical procedures. FUNDING Morbid Obesity Centre, Vestfold Hospital Trust. TRANSLATION For the Norwegian translation of the abstract see Supplementary Materials section.
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Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity.
Kolotkin, RL, Gabriel Smolarz, B, Meincke, HH, Fujioka, K
Clinical obesity. 2018;8(1):1-10
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Obesity is associated with reduced health-related quality of life affecting physical, psychological and social function and well-being. The aim of the study was to determine the durability of improvement of health-related quality of life in participants taking Liraglutide 3.0mg after 3 years. The study included participants with prediabetes who were overweight or obese and presented weight-related conditions (hypertension or dyslipidaemia). Results indicate that participants taking 3.0mg of liraglutide for 3 years saw improvements in obesity-specific and physical aspects of health-related quality of life, and health utility. However, it showed little effects on the mental components when compared to the placebo. Authors conclude that Liraglutide 3.0mg, together with diet and exercise, lead to weight loss in obesity which is linked with improved health related quality of life.
Abstract
Previously in the SCALE Obesity and Prediabetes trial, at 1 year, participants with obesity (or overweight with comorbidities) and prediabetes receiving liraglutide 3.0 mg experienced greater improvements in health-related quality of life (HRQoL) than those receiving placebo. The current study extends these findings by examining 3-year changes in HRQoL. HRQoL was assessed using the obesity-specific Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, as well as the Short-Form 36 v2 (SF-36) health survey. At 3 years, mean change (±standard deviation) in IWQOL-Lite total score from baseline for liraglutide (n = 1472) was 11.0 ± 14.2, vs. 8.1 ± 14.7 for placebo (n = 738) (estimated treatment difference [ETD] 3.4 [95% confidence interval (CI): 2.0, 4.7], P < 0.0001). Mean change in SF-36 physical component summary (PCS) score from baseline for liraglutide was 3.1 ± 7.3, vs. 2.6 ± 7.6 for placebo (ETD 0.87 [95% CI: 0.17, 1.6], P = 0.0156). Mean change in SF-36 mental component summary score did not significantly differ between groups. Both IWQOL-Lite total score and PCS score demonstrated an association between greater HRQoL improvement with higher weight loss. Liraglutide 3.0 mg was also associated with improved health utility (Short-Form-6D and EuroQol-5D, mapped from IWQOL-Lite and/or SF-36) vs. placebo. Liraglutide 3.0 mg, plus diet and exercise, is associated with long-term improvements in HRQoL with obesity or overweight with comorbidity vs. placebo.
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Patient-Reported Outcome Measures 2 Years After Standard and Distal Gastric Bypass-a Double-Blind Randomized Controlled Trial.
Svanevik, M, Risstad, H, Karlsen, TI, Kristinsson, JA, Småstuen, MC, Kolotkin, RL, Søvik, TT, Sandbu, R, Mala, T, Hjelmesæth, J
Obesity surgery. 2018;28(3):606-614
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Bariatric surgery may induce weight loss, improvement of weight-associated comorbidities, and improved health and well-being. The aim of the study is to compare the effects of standard and distal Rou-en-Y gastric bypass on obesity-specific health related quality of life, weight-related symptoms, eating behaviour, anxiety and depression. The study is a double-blind, parallel-group randomised controlled trial. The participants’ age ranged from 18 to 60 years of age with a BMI of 50 to 60 kg/m2. Results indicated improvements in most patient-reported outcome measures after both surgeries, but no significant difference between groups after surgery in relation to obesity-specific health related quality of life, weight-related symptoms, anxiety and depression, or eating behaviour. Authors conclude that both surgeries lead to sustained weight loss and improved health related quality of life 2 years after surgery in patients with a BMI 50-60kg/m2.
Abstract
BACKGROUND The preferred surgical procedure for treating morbid obesity is debated. Patient-reported outcome measures (PROMs) are relevant for evaluation of the optimal bariatric procedure. METHODS A total of 113 patients with BMI from 50 to 60 were randomly assigned to standard (n = 57) or distal (n = 56) Roux-en-Y gastric bypass (RYGB). Validated PROMS questionnaires were completed at baseline and 2 years after surgery. Data were analyzed using mixed models for repeated measures and the results are expressed as estimated means and mean changes. RESULTS Obesity-related quality of life improved significantly after both procedures, without significant between-group differences (- 0.4 (95% CI = - 8.4, 7.2) points, p = 0.88, ES = 0.06). Both groups had significant reductions in the number of weight-related symptoms and symptom distress score, with a mean group difference (95% CI) of 1.4 (- 0.3, 3.3) symptoms and 5.0 (2.9. 12.8) symptom distress score points. There were no between-group differences for uncontrolled eating (22.0 (17.2-26.7) vs. 28.9 (23.3-34.5) points), cognitive restraint (57.4 (52.0-62.7) vs. 62.1 (57.9-66.2) points), and emotional eating (26.8 (20.5-33.1) vs. 32.6 (25.5-39.7) points). The prevalence of anxiety was 33% after standard and 25% after distal RYGB (p = 0.53), and for depression 12 and 9%, respectively (p = 0.76). CONCLUSIONS There were no statistically significant differences between standard and distal RYGB 2 years post surgery regarding weight loss, obesity-related quality of life, weight-related symptoms, anxiety, depression, or eating behavior. TRIAL REGISTRATION Clinical Trials.gov number NCT00821197.
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Health-related quality of life in randomized controlled trials of lorcaserin for obesity management: what mediates improvement?
Kolotkin, RL, Crosby, RD, Wang, Z
Clinical obesity. 2017;(6):347-353
Abstract
Lorcaserin, plus diet and exercise, has demonstrated significant weight loss and improved cardiometabolic parameters vs. placebo in patients with overweight/obesity in three randomized, placebo-controlled trials. We examined whether lorcaserin is also associated with greater improvements in health-related quality of life (HRQOL) and whether these improvements are wholly attributable to weight loss. Pooled data from Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM), Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM) and BLOOM-Diabetes Mellitus (BLOOM-DM) trials were analysed (n = 5624). HRQOL was assessed at baseline and 52 weeks using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire. Multiple mediation analyses were conducted to evaluate the mechanisms underlying improved HRQOL. Greater HRQOL improvements were observed at 52 weeks in lorcaserin vs. placebo (P < 0.0001). A greater percentage of lorcaserin patients (54.1%) experienced meaningful improvements in IWQOL-Lite total score than placebo patients (48.2%) (P < 0.001). Body mass index (BMI) reduction was the primary driver of improved HRQOL (P < 0.0001), with depressive symptoms and total cholesterol also playing a role (P < 0.05). Improved HRQOL varied by gender, age, race and presence of diabetes and other comorbidities. Lorcaserin treatment significantly improves HRQOL compared with placebo. Although BMI reduction accounts for the majority of these improvements, improvement in depressive symptoms and total cholesterol are contributing factors.
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Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.
Kolotkin, RL, Fujioka, K, Wolden, ML, Brett, JH, Bjorner, JB
Clinical obesity. 2016;(4):233-42
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Obesity has a negative impact on health-related quality of life (HRQoL). The SCALE Obesity and Prediabetes study investigated the effect of liraglutide 3.0 mg, as adjunct to diet and exercise, on HRQoL in patients with obesity [body mass index (BMI) ≥ 30 kg m(-2) ] or overweight (BMI ≥ 27 kg m(-2) ) with comorbidity. Participants were advised on a 500 kcal d(-1) deficit diet and a 150-min week(-1) exercise programme and were randomised 2:1 to once-daily subcutaneous liraglutide 3.0 mg or placebo. HRQoL was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Short-Form 36 (SF-36) v2 health questionnaires. Individuals on liraglutide 3.0 mg (n = 2046) had significantly greater improvements in IWQOL-Lite total score (10.6 ± 13.3) vs. placebo (n = 1020) (7.7 ± 12.8) and SF-36 physical (PCS) and mental (MCS) component summary scores (PCS, 3.6 ± 6.8; MCS, 0.2 ± 8.1) vs. placebo (PCS, 2.2 ± 7.7; MCS, -0.9 ± 9.1). The estimated treatment differences were IWQOL-Lite total score 3.1 (95% CI: 2.2; 4.0), P < 0.0001; SF-36 PCS 1.7 (95% CI: 1.2; 2.2), P < 0.0001 and MCS 0.9 (95% CI: 0.3; 1.5), P = 0.003. All subscales of the IWQOL-Lite and SF-36 were significantly improved with liraglutide 3.0 mg vs. placebo. More patients on liraglutide 3.0 mg experienced meaningful improvement on the IWQOL-Lite total (P < 0.0001) and the SF-36 PCS (P < 0.0001) scores.
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Improvements in Functional Exercise Capacity after a Residential Behavioural Change, Diet and Fitness Program for Obese Adults.
Errickson, SP, Kolotkin, RL, Skidmore, MS, Endress, G, Østbye, T, Crosby, R, Eisenson, H
Physiotherapy research international : the journal for researchers and clinicians in physical therapy. 2016;(2):84-90
Abstract
BACKGROUND AND PURPOSE Obese adults are at an increased risk for mobility-related problems. National guidelines recommend calorie restrictions and exercise for obese adults as a means to improve functional fitness capacity and to increase mobility. Yet, lifestyle weight loss interventions often fail to measure fitness changes. The aim of this study was to assess whether a 1-month, intensive behavioural change, diet and fitness intervention for overweight and obese adults would result in statistically significant and clinically meaningful changes in functional exercise. METHODS A pre-post test design was used in this study. Seventy-two participants (40 women, 32 men; mean baseline body mass index (BMI) = 42.6 + 9.0; mean age = 45.8 + 16.8) completed a modified 6-minute walk test (6MWT), performed on a treadmill, at baseline and at end of treatment. RESULTS Significant improvements included decreased BMI (2.7 + 1.7 kg m(-2) , p < 0.001) and increased 6MWT distance (66.4 + 73.0 m, p < 0.001). The 6MWT improved by 66 m on average, a reported clinically meaningful difference. Greater improvements in the 6MWT were significantly correlated with greater weight loss and BMI reduction. DISCUSSION Our findings suggest that rehabilitation beyond weight loss may be derived from participation in a brief, intensive behavioural change, diet and fitness programme. Physiotherapists are in a prime position to address the physical and motivational challenges participants face while living with severe obesity: targeting functional exercise capacity is one key strategy for addressing immobility associated with obesity. Copyright © 2015 John Wiley & Sons, Ltd.
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Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.
Yancy, WS, Mayer, SB, Coffman, CJ, Smith, VA, Kolotkin, RL, Geiselman, PJ, McVay, MA, Oddone, EZ, Voils, CI
Annals of internal medicine. 2015;(12):805-14
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BACKGROUND Choosing a diet rather than being prescribed one could improve weight loss. OBJECTIVE To examine whether offering choice of diet improves weight loss. DESIGN Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). SETTING Outpatient clinic at a Veterans Affairs medical center. PATIENTS Outpatients with a body mass index of at least 30 kg/m2. INTERVENTION Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. MEASUREMENTS The primary outcome was weight at 48 weeks. RESULTS Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. LIMITATIONS Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. CONCLUSION Contrary to expectations, the opportunity to choose a diet did not improve weight loss.
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Factors associated with choice of a low-fat or low-carbohydrate diet during a behavioral weight loss intervention.
McVay, MA, Voils, CI, Coffman, CJ, Geiselman, PJ, Kolotkin, RL, Mayer, SB, Smith, VA, Gaillard, L, Turner, MJ, Yancy, WS
Appetite. 2014;:117-124
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Individuals undertaking a weight loss effort have a choice among proven dietary approaches. Factors contributing to choice of either a low-fat/low-calorie diet or a low-carbohydrate diet, two of the most studied and popular dietary approaches, are unknown. The current study used data from participants randomized to the 'choice' arm of a trial examining whether being able to choose a diet regimen yields higher weight loss than being randomly assigned to a diet. At study entry, participants attended a group session during which they were provided tailored feedback indicating which diet was most consistent with their food preferences using the Geiselman Food Preference Questionnaire (FPQ), information about both diets, and example meals for each diet. One week later, they indicated which diet they chose to follow during the 48-week study, with the option of switching diets after 12 weeks. Of 105 choice arm participants, 44 (42%) chose the low-fat/low-calorie diet and 61 (58%) chose the low-carbohydrate diet. In bivariate analyses, diet choice was not associated with age, race, sex, education, BMI, or diabetes (all p > 0.05). Low-carbohydrate diet choice was associated with baseline higher percent fat intake (p = 0.007), lower percent carbohydrate intake (p = 0.02), and food preferences consistent with a low-carbohydrate diet according to FPQ (p < 0.0001). In a multivariable logistic regression model, only FPQ diet preference was associated with diet choice (p = 0.001). Reported reasons for diet choice were generally similar for those choosing either diet; however, concerns about negative health effects of the unselected diet was rated as more influential among participants selecting the low-fat diet. Only three low-carbohydrate and two low-fat diet participants switched diets at 12 weeks. Results suggest that when provided a choice between two popular weight loss dietary approaches, an individual's selection is likely influenced by baseline dietary intake pattern, and especially by his or her dietary preferences. Research is needed to determine if congruency between food preferences and dietary approach is associated with weight loss.
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Considering patient diet preference to optimize weight loss: design considerations of a randomized trial investigating the impact of choice.
Yancy, WS, Coffman, CJ, Geiselman, PJ, Kolotkin, RL, Almirall, D, Oddone, EZ, Mayer, SB, Gaillard, LA, Turner, M, Smith, VA, et al
Contemporary clinical trials. 2013;(1):106-16
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A variety of diet approaches achieve moderate weight loss in many individuals. Yet, most diet interventions fail to achieve meaningful weight loss in more than a few individuals, likely due to inadequate adherence to the diet. It is widely conjectured that targeting the diet to an individual's food preferences will enhance adherence, thereby improving weight loss. This article describes the design considerations of a study protocol aimed at testing this hypothesis. The study is a 2-arm randomized trial recruiting 216 medical outpatients with BMI ≥30 kg/m(2) followed for 48 weeks. Participants in the experimental arm (Choice) select from two of the most widely studied diets for weight loss, a low-carbohydrate, calorie-unrestricted diet (LCD) or a low-fat, reduced-calorie diet (LFD). The participant's choice is informed by results from a validated food preference questionnaire and a discussion of diet options with trained personnel. Choice participants are given the option to switch to the other diet after three months, if desired. Participants in the Control arm are randomly assigned to follow one of the two diets for the duration of follow-up. The primary outcome is weight assessed every 2-4 weeks for 48 weeks. Secondary outcomes include adherence to diet by food frequency questionnaire and obesity-specific health-related quality of life. If assisting patients to choose their diet enhances adherence and increases weight loss, the results will support the provision of diet options to patients who desire weight loss, and bring us one step closer to remediating the obesity epidemic faced by our healthcare systems.
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Effects of two weight-loss diets on health-related quality of life.
Yancy, WS, Almirall, D, Maciejewski, ML, Kolotkin, RL, McDuffie, JR, Westman, EC
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2009;(3):281-9
Abstract
PURPOSE To compare the effects of two diets on health-related quality of life (HRQOL). METHODS Overweight volunteers (n = 119) were randomized to follow a low-carbohydrate, ketogenic diet (LCKD) or a low-fat diet (LFD) for 24 weeks. HRQOL was measured every 4 weeks using the Short Form-36 and analyzed using linear mixed-effects models. RESULTS The mean age was 45 years and mean baseline body mass index was 34 kg/m(2); 76% were women. At 24 weeks, five subscales (Physical Functioning, Role-Physical, General Health, Vitality, Social Functioning) and the Physical Component Summary score improved similarly in both diet groups. Bodily Pain improved in the LFD group only, whereas the Role-Emotional and Mental Health subscales and the Mental Component Summary (MCS) score improved in the LCKD group only. In comparison with the LFD group, the LCKD group had a statistically significant greater improvement in MCS score (3.1; 95%CI 0.2-6.0; effect size = 0.44) and a borderline significant greater improvement in the Mental Health subscale (5.0; 95%CI -0.3-10.4; effect size = 0.37). CONCLUSIONS Mental aspects of HRQOL improved more in participants following an LCKD than an LFD, possibly resulting from the LCKD's composition, lack of explicit energy restriction, higher levels of satiety or metabolic effects.