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Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.

ABSTRACT: Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus (T2DM).To determine feasibility of a randomized clinical trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity.A 12-month, 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 30 to 40 and T2DM.Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and an intensive lifestyle weight loss intervention (LWLI).Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control.Of 667 potential participants who underwent screening, 69 (10.3%) were randomized. Among the randomized participants, 30 (43%) had grade I obesity, and 56 (81%) were women. Mean (SD) age was 47.3 (6.4) years and hemoglobin A1c level, 7.9% (2.0%). After randomization, 7 participants (10%) refused to undergo their allocated intervention (3 RYGB, 1 LAGB, and 3 LWLI), and 1 RYGB participant was excluded for current smoking. Twenty participants underwent RYGB; 21, LAGB; and 20, LWLI, with 12-month retention rates of 90%, 86%, and 70%, respectively. In the intention-to-treat cohort with multiple imputation for missing data, RYGB participants had the greatest mean weight loss from baseline (27.0%; 95% CI, 30.8-23.3) compared with LAGB (17.3%; 95% CI, 21.1-13.5) and LWLI (10.2%; 95% CI, 14.8-5.61) (P?

SUBMITTER: Courcoulas AP

PROVIDER: S-EPMC4106661 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.

Courcoulas Anita P AP Goodpaster Bret H BH Eagleton Jessie K JK Belle Steven H SH Kalarchian Melissa A MA Lang Wei W Toledo Frederico G S FG Jakicic John M JM

JAMA surgery 20140701 7

<h4>Importance</h4>Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus (T2DM).<h4>Objective</h4>To determine feasibility of a randomized clinical trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity.<h4>Design, setting, and participants</h4>A 12-month, 3-arm RCT at a single center including 69 participants aged 25 to 55 years with ...[more]

PMID: 24899268

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Project description:ImportanceQuestions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM).ObjectiveTo compare the remission of T2DM following surgical and nonsurgical treatments.Design, setting, and participantsIn this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population.InterventionsParticipants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.Main outcomes and measuresPrimary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change.ResultsBody mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01).Conclusions and relevanceAmong obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone.Trial registrationclinicaltrials.gov Identifier: NCT01047735.

Project description:ImportanceControlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown.ObjectiveTo compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors.Design, setting, and participantsA 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008.InterventionsLifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized.Main outcomes and measuresComposite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg.ResultsAll 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group.Conclusions and relevanceIn mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events.Trial registrationclinicaltrials.gov Identifier: NCT00641251.

Project description:ImportanceTo better understand the emerging role of artificial intelligence (AI) in surgical training, efficacy of AI tutoring systems, such as the Virtual Operative Assistant (VOA), must be tested and compared with conventional approaches.ObjectiveTo determine how VOA and remote expert instruction compare in learners' skill acquisition, affective, and cognitive outcomes during surgical simulation training.Design, setting, and participantsThis instructor-blinded randomized clinical trial included medical students (undergraduate years 0-2) from 4 institutions in Canada during a single simulation training at McGill Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal, Canada. Cross-sectional data were collected from January to April 2021. Analysis was conducted based on intention-to-treat. Data were analyzed from April to June 2021.InterventionsThe interventions included 5 feedback sessions, 5 minutes each, during a single 75-minute training, including 5 practice sessions followed by 1 realistic virtual reality brain tumor resection. The 3 intervention arms included 2 treatment groups, AI audiovisual metric-based feedback (VOA group) and synchronous verbal scripted debriefing and instruction from a remote expert (instructor group), and a control group that received no feedback.Main outcomes and measuresThe coprimary outcomes were change in procedural performance, quantified as Expertise Score by a validated assessment algorithm (Intelligent Continuous Expertise Monitoring System [ICEMS]; range, -1.00 to 1.00) for each practice resection, and learning and retention, measured from performance in realistic resections by ICEMS and blinded Objective Structured Assessment of Technical Skills (OSATS; range 1-7). Secondary outcomes included strength of emotions before, during, and after the intervention and cognitive load after intervention, measured in self-reports.ResultsA total of 70 medical students (41 [59%] women and 29 [41%] men; mean [SD] age, 21.8 [2.3] years) from 4 institutions were randomized, including 23 students in the VOA group, 24 students in the instructor group, and 23 students in the control group. All participants were included in the final analysis. ICEMS assessed 350 practice resections, and ICEMS and OSATS evaluated 70 realistic resections. VOA significantly improved practice Expertise Scores by 0.66 (95% CI, 0.55 to 0.77) points compared with the instructor group and by 0.65 (95% CI, 0.54 to 0.77) points compared with the control group (P < .001). Realistic Expertise Scores were significantly higher for the VOA group compared with instructor (mean difference, 0.53 [95% CI, 0.40 to 0.67] points; P < .001) and control (mean difference. 0.49 [95% CI, 0.34 to 0.61] points; P < .001) groups. Mean global OSATS ratings were not statistically significant among the VOA (4.63 [95% CI, 4.06 to 5.20] points), instructor (4.40 [95% CI, 3.88-4.91] points), and control (3.86 [95% CI, 3.44 to 4.27] points) groups. However, on the OSATS subscores, VOA significantly enhanced the mean OSATS overall subscore compared with the control group (mean difference, 1.04 [95% CI, 0.13 to 1.96] points; P = .02), whereas expert instruction significantly improved OSATS subscores for instrument handling vs control (mean difference, 1.18 [95% CI, 0.22 to 2.14]; P = .01). No significant differences in cognitive load, positive activating, and negative emotions were found.Conclusions and relevanceIn this randomized clinical trial, VOA feedback demonstrated superior performance outcome and skill transfer, with equivalent OSATS ratings and cognitive and emotional responses compared with remote expert instruction, indicating advantages for its use in simulation training.Trial registrationClinicalTrials.gov Identifier: NCT04700384.

Project description:Importance:Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity. Objective:To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss. Design, Setting, and Participants:This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention. Interventions:Participants randomized to the GMV group (n?=?136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n?=?127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits). Main Outcomes and Measures:Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions. Results:Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, -0.1%; 95% CI, -0.5% to 0.2%; upper 95% CI, <0.5% threshold; P?=?.44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P?<?.001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P?<?.001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P?<?.001) during the 48-week period. Conclusions and Relevance:In GMVs for diabetes, addition of WM using a low-carbohydrate diet was noninferior for lowering HbA1c levels compared with conventional medication management and showed advantages in other clinically important outcomes. Trial Registration:ClinicalTrials.gov identifier: NCT01973972.

Project description:ImportanceEarly-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes.ObjectiveTo compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity.Design, setting, and participantsFor this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up.InterventionA total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51).Main outcomes and measuresThe primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety.ResultsA total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed.Conclusions and relevanceAfter 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.Trial registrationClinicalTrials.gov Identifier: NCT01821508.

Project description:BackgroundThis study aimed at assessing the long-term effects of intranasal insulin (INI) on cognition and gait in older people with and without type 2 diabetes mellitus (T2DM).MethodsPhase 2 randomized, double-blinded trial consisted of 24 week treatment with 40 IU of INI (Novolin® R, off-label use) or placebo (sterile saline) once daily and 24 week follow-up. Primary outcomes were cognition, normal (NW), and dual-task (DTW) walking speeds. Of 244 randomized, 223 completed baseline (51 DM-INI, 55 DM-Placebo, 58 Control-INI, 59 Control-Placebo; 109 female, 65.8 ± 9.1; 50-85 years old); 174 completed treatment (84 DM, 90 Controls); 156 completed follow-up (69 DM).ResultsDM-INI had faster NW (~ 7 cm/s; p = 0.025) and DTW on-treatment (p = 0.007; p = 0.812 adjusted for baseline difference) than DM-Placebo. Control-INI had better executive functioning on-treatment (p = 0.008) and post-treatment (p = 0.007) and verbal memory post-treatment (p = 0.004) than Control-Placebo. DM-INI increased cerebral blood flow in medio-prefrontal cortex (p < 0.001) on MRI. Better vasoreactivity was associated with faster DTW (p < 0.008). In DM-INI, plasma insulin (p = 0.006) and HOMA-IR (p < 0.013) decreased post-treatment. Overall INI effect demonstrated faster walking (p = 0.002) and better executive function (p = 0.002) and verbal memory (p = 0.02) (combined DM-INI and Control-INI cohort, hemoglobin A1c-adjusted). INI was not associated with serious adverse events, hypoglycemic episodes, or weight gain.ConclusionThere is evidence for positive INI effects on cognition and gait. INI-treated T2DM participants walked faster, showed increased cerebral blood flow and decreased plasma insulin, while controls improved executive functioning and verbal memory. The MemAID trial provides proof-of-concept for preliminary safety and efficacy and supports future evaluation of INI role to treat T2DM and age-related functional decline.

Dataset Information

Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.

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Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.

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