human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The frequency of anemia , iron deficiency , and the long-term need for IV iron  following Roux-en-y gastric bypass ( RYGB ) surgery  has not been well characterized . Three-hundred and nineteen out of 904 consecutive subjects who underwent RYGB at Penn State Hershey Medical Center from 1999 to 2006 met the inclusion criteria for a preoperative complete blood count ( CBC ) and at least one CBC > 6 months following surgery . Cumulative incidence of anemia 7 years post procedure was 58 % . Menstruation status and presence of preoperative anemia were predictive of anemia by univariate analysis and multivariable Cox regression ( P= 0.0014 and 0.044 , respectively ) . Twenty-seven subjects , primarily premenopausal women , representing 8.5 % of the cohort and 22 % of the 122 anemic subjects , needed intravenous ( IV ) iron  a mean of 51 months postoperatively for anemia unresponsive or refractory to oral iron . The risk for development of anemia necessitating IV iron therapy following RYGB is highest in menstruating women and continues to increase for many years , even in post-menopausal women . Well- design ed prospect i ve studies are needed to identify the incidence of iron deficiency anemia and the patient population s at increased risk for requiring IV iron replacement after RYGB surgery IMPORTANCE Controlling glycemia , blood pressure , and cholesterol is important for patients with diabetes . How best to achieve this goal is unknown . OBJECTIVE To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 2-group unblinded r and omized 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 . INTERVENTIONS Lifestyle-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 st and ardized . MAIN OUTCOMES AND MEASURES Composite 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 . RESULTS All 120 patients received the intensive lifestyle-medical management protocol and 60 were r and omly 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 RELEVANCE In 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 REGISTRATION clinical trials.gov Identifier : NCT00641251 Background Roux-en-Y gastric bypass ( GBP ) and sleeve gastrectomy ( SG ) have increased dramatically , potentially increasing the prevalence of nutritional deficiencies . The aim of this study was to analyze the effects of food restriction during the first year after  bariatric surgery ( BS ) on nutritional parameters . Methods Twenty-two and 30 obese patients undergoing GBP and SG  were prospect ively followed at baseline and 3 , 6 , and 12 months after BS ( N = 14 and N = 19 at T12 ) . We evaluated food intake and nutrient adequacy ( T0 , T3 , T12 ) , as well as serum vitamin and mineral concentration ( T0 , T3 , T6 , T12 ) . Results At baseline , GBP and SG patients had similar clinical characteristics , food intake , nutrient adequacy , and serum concentration . The drastic energy and food reduction led to very low probabilities of adequacy for nutrients similar in both models ( T3 , T12 ) . Serum analysis demonstrated a continuous decrease in prealbumin during the follow-up , indicating mild protein depletion in 37 and 38 % of GBP patients and 57 and 52 % of SG patients , respectively , at T3 and T12 . Conversely , despite the low probabilities of adequacy observed at T3 and T12 , systematic multivitamin and mineral supplementation after GBP and SG prevented most nutritional deficiencies . Conclusions GBP and SG have comparable effects in terms of energy and food restriction and subsequent risk of micronutrient and protein deficiencies in the first year post BS . Such results advocate for a cautious monitoring of protein intake after GPB and SG and a systematic multivitamin and mineral supplementation in the first year after SG OBJECTIVE —The effectiveness of intentional weight loss in reducing cardiovascular disease ( CVD ) events in type 2 diabetes is unknown . This report describes 1-year changes in CVD risk factors in a trial design ed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events . RESEARCH DESIGN AND METHODS —This study consisted of a multicentered , r and omized , controlled trial of 5,145 individuals with type 2 diabetes , aged 45–74 years , with BMI > 25 kg/m2 ( > 27 kg/m2 if taking insulin ) . An intensive lifestyle intervention ( ILI ) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education ( DSE ) condition . RESULTS — Participants assigned to ILI lost an average 8.6 % of their initial weight vs. 0.7 % in DSE group ( P < 0.001 ) . Mean fitness increased in ILI by 20.9 vs. 5.8 % in DSE ( P < 0.001 ) . A greater proportion of ILI participants had reductions in diabetes , hypertension , and lipid-lowering medicines . Mean A1C dropped from 7.3 to 6.6 % in ILI ( P < 0.001 ) vs. from 7.3 to 7.2 % in DSE . Systolic and diastolic pressure , triglycerides , HDL cholesterol , and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants ( all P < 0.01 ) . CONCLUSIONS —At 1 year , ILI result ed in clinical ly significant weight loss in people with type 2 diabetes . This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE . Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk 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 r and omized 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 r and omized trials are performed . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01073020 Summary Bariatric surgery is currently the most effective procedure for the treatment of obesity . Given the role of the gut microbiota in regulating host metabolism and adiposity , we investigated the long-term effects of bariatric surgery on the microbiome of patients r and omized to Roux-en-Y gastric bypass or vertical b and ed gastroplasty and matched for weight and fat mass loss . The two surgical procedures induced similar and durable changes on the gut microbiome that were not dependent on body mass index and result ed in altered levels of fecal and circulating metabolites compared with obese controls . By colonizing germ-free mice with stools from the patients , we demonstrated that the surgically altered microbiota promoted reduced fat deposition in recipient mice . These mice also had a lower respiratory quotient , indicating decreased utilization of carbohydrates as fuel . Our results suggest that the gut microbiota may play a direct role in the reduction of adiposity observed after bariatric surgery Objective : Laparoscopic sleeve gastrectomy ( LSG ) has been proposed as an effective alternative to the current st and ard procedure , laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . Prospect i ve data comparing both procedures are rare . Therefore , we performed a r and omized clinical trial assessing the effectiveness and safety of these 2 operative techniques . Methods : Two hundred seventeen patients were r and omized at 4 bariatric centers in Switzerl and . One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line , and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb . The mean body mass index of all patients was 44 ± 11.1 kg/m2 , the mean age was 43 ± 5.3 years , and 72 % were female . Results : The 2 groups were similar in terms of body mass index , age , sex , comorbidities , and eating behavior . 
    Output:
    
agent
The medicine use and quality of life were solely improved in the surgical group .
Nutritional deficiencies and anemia were noted more frequently in the RYGB group .
RYGB surgery is superior to medical treatment for short- to medium-term remission of T2DM , improvement of metabolic condition , and cardiovascular risk factors .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The frequency of anemia , iron deficiency , and the long-term need for IV iron  following Roux-en-y gastric bypass ( RYGB ) surgery  has not been well characterized . Three-hundred and nineteen out of 904 consecutive subjects who underwent RYGB at Penn State Hershey Medical Center from 1999 to 2006 met the inclusion criteria for a preoperative complete blood count ( CBC ) and at least one CBC > 6 months following surgery . Cumulative incidence of anemia 7 years post procedure was 58 % . Menstruation status and presence of preoperative anemia were predictive of anemia by univariate analysis and multivariable Cox regression ( P= 0.0014 and 0.044 , respectively ) . Twenty-seven subjects , primarily premenopausal women , representing 8.5 % of the cohort and 22 % of the 122 anemic subjects , needed intravenous ( IV ) iron  a mean of 51 months postoperatively for anemia unresponsive or refractory to oral iron . The risk for development of anemia necessitating IV iron therapy following RYGB is highest in menstruating women and continues to increase for many years , even in post-menopausal women . Well- design ed prospect i ve studies are needed to identify the incidence of iron deficiency anemia and the patient population s at increased risk for requiring IV iron replacement after RYGB surgery IMPORTANCE Controlling glycemia , blood pressure , and cholesterol is important for patients with diabetes . How best to achieve this goal is unknown . OBJECTIVE To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 2-group unblinded r and omized 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 . INTERVENTIONS Lifestyle-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 st and ardized . MAIN OUTCOMES AND MEASURES Composite 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 . RESULTS All 120 patients received the intensive lifestyle-medical management protocol and 60 were r and omly 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 RELEVANCE In 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 REGISTRATION clinical trials.gov Identifier : NCT00641251 Background Roux-en-Y gastric bypass ( GBP ) and sleeve gastrectomy ( SG ) have increased dramatically , potentially increasing the prevalence of nutritional deficiencies . The aim of this study was to analyze the effects of food restriction during the first year after  bariatric surgery ( BS ) on nutritional parameters . Methods Twenty-two and 30 obese patients undergoing GBP and SG  were prospect ively followed at baseline and 3 , 6 , and 12 months after BS ( N = 14 and N = 19 at T12 ) . We evaluated food intake and nutrient adequacy ( T0 , T3 , T12 ) , as well as serum vitamin and mineral concentration ( T0 , T3 , T6 , T12 ) . Results At baseline , GBP and SG patients had similar clinical characteristics , food intake , nutrient adequacy , and serum concentration . The drastic energy and food reduction led to very low probabilities of adequacy for nutrients similar in both models ( T3 , T12 ) . Serum analysis demonstrated a continuous decrease in prealbumin during the follow-up , indicating mild protein depletion in 37 and 38 % of GBP patients and 57 and 52 % of SG patients , respectively , at T3 and T12 . Conversely , despite the low probabilities of adequacy observed at T3 and T12 , systematic multivitamin and mineral supplementation after GBP and SG prevented most nutritional deficiencies . Conclusions GBP and SG have comparable effects in terms of energy and food restriction and subsequent risk of micronutrient and protein deficiencies in the first year post BS . Such results advocate for a cautious monitoring of protein intake after GPB and SG and a systematic multivitamin and mineral supplementation in the first year after SG OBJECTIVE —The effectiveness of intentional weight loss in reducing cardiovascular disease ( CVD ) events in type 2 diabetes is unknown . This report describes 1-year changes in CVD risk factors in a trial design ed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events . RESEARCH DESIGN AND METHODS —This study consisted of a multicentered , r and omized , controlled trial of 5,145 individuals with type 2 diabetes , aged 45–74 years , with BMI > 25 kg/m2 ( > 27 kg/m2 if taking insulin ) . An intensive lifestyle intervention ( ILI ) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education ( DSE ) condition . RESULTS — Participants assigned to ILI lost an average 8.6 % of their initial weight vs. 0.7 % in DSE group ( P < 0.001 ) . Mean fitness increased in ILI by 20.9 vs. 5.8 % in DSE ( P < 0.001 ) . A greater proportion of ILI participants had reductions in diabetes , hypertension , and lipid-lowering medicines . Mean A1C dropped from 7.3 to 6.6 % in ILI ( P < 0.001 ) vs. from 7.3 to 7.2 % in DSE . Systolic and diastolic pressure , triglycerides , HDL cholesterol , and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants ( all P < 0.01 ) . CONCLUSIONS —At 1 year , ILI result ed in clinical ly significant weight loss in people with type 2 diabetes . This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE . Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk 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 r and omized 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 r and omized trials are performed . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01073020 Summary Bariatric surgery is currently the most effective procedure for the treatment of obesity . Given the role of the gut microbiota in regulating host metabolism and adiposity , we investigated the long-term effects of bariatric surgery on the microbiome of patients r and omized to Roux-en-Y gastric bypass or vertical b and ed gastroplasty and matched for weight and fat mass loss . The two surgical procedures induced similar and durable changes on the gut microbiome that were not dependent on body mass index and result ed in altered levels of fecal and circulating metabolites compared with obese controls . By colonizing germ-free mice with stools from the patients , we demonstrated that the surgically altered microbiota promoted reduced fat deposition in recipient mice . These mice also had a lower respiratory quotient , indicating decreased utilization of carbohydrates as fuel . Our results suggest that the gut microbiota may play a direct role in the reduction of adiposity observed after bariatric surgery Objective : Laparoscopic sleeve gastrectomy ( LSG ) has been proposed as an effective alternative to the current st and ard procedure , laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . Prospect i ve data comparing both procedures are rare . Therefore , we performed a r and omized clinical trial assessing the effectiveness and safety of these 2 operative techniques . Methods : Two hundred seventeen patients were r and omized at 4 bariatric centers in Switzerl and . One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line , and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb . The mean body mass index of all patients was 44 ± 11.1 kg/m2 , the mean age was 43 ± 5.3 years , and 72 % were female . Results : The 2 groups were similar in terms of body mass index , age , sex , comorbidities , and eating behavior . 
    Output:
    