Roux-en-Y Gastric Bypass Surgery or Lifestyle With Intensive Medical Management in Patients With Type 2 Diabetes

Abstract

IMPORTANCE Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. OBJECTIVE To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A1c (HbA1c) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications. INTERVENTIONS RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter. MAIN OUTCOMES AND MEASURES Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes. RESULTS At 1 year, the proportion of patients achieving HbA1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA1c, weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life–Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life–Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT. CONCLUSIONS AND RELEVANCE In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed.

The effectiveness of bariatric surgery on long term psychosocial quality of life – A systematic review

“…Two of the eleven included studies were RCTs [51,52]. Six of the studies included in this review had a strong overall quality rating, according to the EPHPP quality assessment tool used ( Table 2).…”

“…The most commonly cited co-morbidities were diabetes and cardiovascular disease. The individual study sample size ranged from 43 to 1276 [52,39]. The majority of participants in the studies were female and mean age ranged from 39 years [55] to 48 years [39] which is representative of the BS population in the UK [14] Group differences in baseline characteristics were noted in most of the studies apart from the four controlled trials [51,52,56,39] and Buddeberg-Fischer et al [54].…”

“…The individual study sample size ranged from 43 to 1276 [52,39]. The majority of participants in the studies were female and mean age ranged from 39 years [55] to 48 years [39] which is representative of the BS population in the UK [14] Group differences in baseline characteristics were noted in most of the studies apart from the four controlled trials [51,52,56,39] and Buddeberg-Fischer et al [54]. The general trend being that the surgery group tended to be significantly younger, with greater weight or BMI than the no surgery group [55] or population based obese control group [57][58][59][60].…”

“…Other measures used were the EuroQol 5 Dimensions (EQ-5D) scale [51,52], Linear Analogue Self Assessment (LASA) questionnaire and SF-12, a short form of the SF-36 [53], the Psychosocial Stress and Symptom Questionnaire [54], the Current Health Scale, Mood Adjective Checklist (MACL), Obesity-related Problems Scale (OP) and Sickness Impact Profile (SIP).…”

Recent advancements in bariatric/metabolic surgery

“…This study compared LSG to gastric bypass (LSAGB) for the treatment of T2DM in Asian patients with BMI <35 kg/m 2 and was the first study to prove that gastric bypass (a duodenum exclusion procedure) had better efficacy on T2DM remission than LSG (non‐duodenum exclusion procedure). Following this landmark study, many RCT focusing on the comparison of metabolic surgery and medical treatment for the treatment of T2DM have been carried out and universally showed that metabolic surgery is more effective than medical treatment in glycemic control 91, 92, 93, 94, 95, 96, 97, 98, 99. Table 2 lists the results of RCT trials on surgical treatment versus medical treatment for T2DM.…”