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: Background The TANTALUS system ( MetaCure Ltd. ) is a minimally invasive implantable gastric stimulation modality that does not exhibit malabsorptive or restrictive characteristics . The device applies gastric contractility modulation ( GCM ) signals to the stomach antrum . The signals are delivered in synchronization to the native electrical activity of the stomach during meals . Retrospective analysis of previous studies indicated that type 2 diabetes mellitus ( T2DM ) subjects on oral medication with hemoglobin A1c ( HbA1c ) between 7.5 % and 9.5 % are the population with most potential benefit from the treatment . The current study includes subjects enrolled prospect ively within that range of HbA1c . Aim To prospect ively investigate the potential effect of the TANTALUS system on glycemic control and weight in overweight subjects with T2DM . Methods In this European multicenter , open-label study , 13 T2DM obese ( 6 male , 7 female , BMI 37.2 ± 1.0 kg/m2 , range 30.4–44.0 kg/m2 ) subjects treated with oral antidiabetic medications but with poor glycemic control ( HbA1c ≥ 7 % , range 7.3–9.5 % ) were implanted laparoscopically with the TANTALUS system . Results Thirteen subjects that had completed 3 months of treatment showed a significant reduction in HbA1c from 8.0 ± 0.2 % to 6.9 ± 0.1 % ( p < 0.05 ) , whereas fasting blood glucose decreased from 175 ± 6 mg/dL to 127 ± 8 mg/dL ( p < 0.05 ) . The glycemic improvement was accompanied by reduction in weight from 104.4 ± 4.4 kg to 99.7 ± 4.8 kg , and in waist circumference from 122.3 ± 3.2 cm to 117.0 ± 3.0 cm . Conclusions Interim results with the TANTALUS system suggest that this stimulation regime can potentially improve glucose levels and induce moderate weight loss in obese T2DM subjects on oral antidiabetic therapy with poor glycemic control . Further evaluation is required to determine whether this effect is due to induced weight loss and /or due to direct signal-dependent mechanisms This report describes the authors ’ early outcomes with implantable gastric stimulation ( IGS ) used to achieve weight loss in patients with a low body mass index ( BMI ) . After prescreening of potential c and i date s with a selection algorithm , 24 patients ( 21 women and 3 men ) with a low BMI ( 30–34.9 ) underwent IGS implantation at two centers . The patients had a mean age of 43 years ( range , 32–60 years ) , a mean BMI of 33 ( range , 30–36 ) , and a mean weight of 92 kg ( range , 80–117 kg ) . At this writing , 6 months postoperatively , there have been no serious adverse events related to the device . The mean percentage of excess weight loss ( EWL ) was 5.9 % , with three patients explanted because of noncompliance . The mean waist circumference decreased 5.8 % , which was significant ( p = 0.009 ) . A subset of nine patients ( 37.5 % ) had an EWL exceeding 10 % ( mean , 20.1 % ) . A subset of low BMI patients lost a clinical ly significant amount of weight with IGS within 6 months . Further study is required for better identification of potential c and i date s for this novel approach Obesity is one of the most prevalent health problems in the world with a lack of satisfactory therapies and gastric electrical stimulation has recently been proposed for the treatment of obesity . The aim of this study was to investigate the effects of retro grade gastric pacing ( RGP ) on food and water intake , and gastric emptying in humans .  RGP with a tachygastrial frequency of 9 cycles/min was performed via a pair of submucosal gastric electrodes implanted 5 cm above the pylorus in 12 subjects . The water load test , food intake test and scintigraphic gastric emptying test were performed to assess the efficacy of RGP . RGP result ed in a 13 % reduction in the consumption of water , a 16 % reduction in food intake and a 15 % increase in gastric retention of a solid meal . No significant symptoms were recorded with RGP using the parameters used for the water-load , food intake and scintigraphic gastric emptying tests . Acute RGP at a tachygastrial frequency results in a significant reduction of water and food intake and a delay in gastric emptying without inducing any unacceptable symptoms . It is worthy to explore its therapeutic potential for obesity Background Non-stimulatory , meal-mediated electrical stimulation of the stomach ( TANTALUS-DIAMOND ) improves glycaemic control and causes modest weight loss in patients with Type 2 diabetes who are inadequately controlled on oral anti-diabetic medications . The magnitude of the glycaemic response in clinical studies has been variable . A preliminary analysis of data from patients who had completed 6 months of treatment indicated that the glycaemic response to the electrical stimulation was inversely related to the baseline fasting plasma triglyceride level . Method An analysis of 40 patients who had had detailed longitudinal studies for 12 months . Results Twenty-two patients with fasting plasma triglycerides ≤ 1.7 mmol/l had mean decreases in HbA1c after 3 , 6 and 12 months of gastric contraction modulation treatment of −15 ± 2.1 mmol/mol ( −1.39 ± 0.20 % ) , −16 ± 2.2 mmol/mol ( −1.48 ± 0.20 % ) and −14 ± 3.0 mmol/mol ( −1.31 ± 0.26 % ) , respectively . In contrast , 18 patients with fasting plasma triglyceride > 1.7 mmol/l had mean decreases in HbA1c of −7 ± 1.7 mmol/mol ( −0.66 ± 0.16 % ) , −5 ± 1.6 mmol/mol ( −0.44 ± 0.18 % ) and −5 ± 1.7 mmol/mol ( −0.42 ± 0.16 % ) , respectively . Pearson 's correlation coefficient between fasting plasma triglyceride and decreases in HbA1c at 12 months of treatment was 0.34 ( P < 0.05 ) . Homeostasis model assessment of insulin resistance was unchanged during 12 months of treatment in patients with high baseline fasting triglycerides , while it progressively improved in patients with low fasting plasma triglycerides . Patients with low fasting plasma triglycerides had a tendency to lose more weight than those with high fasting plasma triglycerides , but this did not achieve statistical significance . Conclusions The data presented suggest the existance of a triglyceride lipotoxic mechanism that interferes with gastric/neural mediated pathways that can regulate glycaemic control in patients with type 2 diabetes . The data suggest the existence of a triglyceride lipotoxic pathway that interferes with gastric/neural mediated pathways that can regulate glycaemic control BACKGROUND To compare implantable gastric stimulation therapy with a st and ard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss ( EWL ) between the control and treatment groups . The primary endpoint was the percentage of EWL from baseline to 12 months after r and omization . Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients ; however , previous investigations have reported inconclusive results . METHODS A total of 190 subjects were enrolled in this prospect i ve , r and omized , placebo-controlled , double-blind , multicenter study . All patients underwent implantation with the implantable gastric stimulator and were r and omized to 1 of 2 treatment groups : the control group ( stimulation off ) or treatment group ( stimulation on ) . The patients were evaluated on a monthly basis . All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings . RESULTS The procedure result ed in no deaths and a low complication rate . The primary endpoint of a difference in weight loss between the treatment and control groups was not met . The control group lost 11.7 % + /- 16.9 % of excess weight and the treatment group lost 11.8 % + /- 17.6 % ( P = .717 ) according to an intent-to-treat analysis . CONCLUSION Implantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations . However , the results of the present study do not support its application . Additional research is indicated to underst and the physiology and potential benefits of this therapy Background : The TANTALUS ® System is an investigational device that consists of an implantable pulse generator connected to gastric electrodes . The system is design ed to automatically detect when eating starts and only then deliver sessions of gastric electrical stimulation ( GES ) with electrical pulses that are synchronized to the intrinsic antral slow waves . We report the effect of this type of GES on weight loss and glucose control in overweight/obese subjects with type 2 diabetes mellitus ( T2DM ) . This study was conducted under a Food and Drug Administration/Institutional Review Board-approved investigational device exemption . Method : Fourteen obese T2DM subjects on oral antidiabetes medication were enrolled and implanted laparoscopically with the TANTALUS System ( body mass index 39 ± 1 kg/m2 , hemoglobin A1c [ HbA1c ] 8.5 ± 0.2 % ) . Gastric electrical stimulation was initiated four weeks after implantation . Weight , HbA1c , fasting blood glucose , blood pressure , and lipid levels were assessed during the study period . Results : Eleven subjects reached the 6-month treatment period endpoint . Gastric electrical stimulation was well tolerated by all subjects . In those patients completing 6 months of therapy , HbA1c was reduced significantly from 8.5 ± 0.7 % to 7.6 ± 1 % , p < .01 . Weight was also significantly reduced from 107.7 ± 21.1 to 102.4 ± 20.5 kg , p < .01 . The improvement in glucose control did not correlate with weight loss ( R 2 = 0.05 , p = .44 ) . A significant improvement was noted in blood pressure , triglycerides , and cholesterol ( low-density lipoprotein only ) . Conclusions : Short-term therapy with the TANTALUS System  improves glucose control , induces weight loss , and improves blood pressure and lipids in obese T2DM subjects on oral antidiabetes therapy Background Gastric electrical stimulation ( GES ) , using the implantable TANTALUSTM System , is being explored as a treatment for obesity . The system delivers nonstimulatory electrical signals synchronized with gastric slow waves , result ing in stronger contractions . We hypothesized that this GES may enhance gastric emptying and as a result affect plasma ghrelin and insulin homeostasis . The aim was to test the effect of GES on gastric emptying of solids and on ghrelin and insulin blood levels in obese subjects . Methods The system consists of 3 pairs of gastric electrodes connected to an implantable pulse generator . Gastric emptying test  ( GE ) of solids was performed twice , on separate days , a few weeks after implantation , before and after initiation of stimulation . Blood sample s for ghrelin and insulin were taken at baseline and at 15 , 30 , 60 and 120 min after the test meal . Results There were 11 females , 1 male , mean age 39.1 ± 8.9 years , mean BMI 41.6 ± 3.4 . Data is available from 11 subjects ; GE was normal in 9 subjects and accelerated in 2 subjects  . GES significantly accelerated GE compared to control : percent retention at 2 hours 18.7 ± 12.2 vs 31.9 ± 16.4 , respectively ( P < 0.01 ) . Overall , there was no significant change in ghrelin or insulin profile after food intake . Ghrelin levels fell significantly at 60 min compared to baseline during stimulation ( P = 0.014 ) and control ( P = 0.046 ) . Conclusion GES results in a significant acceleration of gastric emptying of solids in obese subjects . GES did not have a significant effect on postpr and ial ghrelin levels when compared to control BACKGROUND A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss ( EWL ) in an initial clinical trial in obese patients . The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia , Norway , and Switzerl and . METHODS Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms . In the second trial , vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device . The patients were followed up for 6 months to assess the EWL and safety , including adverse events . 
    Output:
    
agent
***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: Background The TANTALUS system ( MetaCure Ltd. ) is a minimally invasive implantable gastric stimulation modality that does not exhibit malabsorptive or restrictive characteristics . The device applies gastric contractility modulation ( GCM ) signals to the stomach antrum . The signals are delivered in synchronization to the native electrical activity of the stomach during meals . Retrospective analysis of previous studies indicated that type 2 diabetes mellitus ( T2DM ) subjects on oral medication with hemoglobin A1c ( HbA1c ) between 7.5 % and 9.5 % are the population with most potential benefit from the treatment . The current study includes subjects enrolled prospect ively within that range of HbA1c . Aim To prospect ively investigate the potential effect of the TANTALUS system on glycemic control and weight in overweight subjects with T2DM . Methods In this European multicenter , open-label study , 13 T2DM obese ( 6 male , 7 female , BMI 37.2 ± 1.0 kg/m2 , range 30.4–44.0 kg/m2 ) subjects treated with oral antidiabetic medications but with poor glycemic control ( HbA1c ≥ 7 % , range 7.3–9.5 % ) were implanted laparoscopically with the TANTALUS system . Results Thirteen subjects that had completed 3 months of treatment showed a significant reduction in HbA1c from 8.0 ± 0.2 % to 6.9 ± 0.1 % ( p < 0.05 ) , whereas fasting blood glucose decreased from 175 ± 6 mg/dL to 127 ± 8 mg/dL ( p < 0.05 ) . The glycemic improvement was accompanied by reduction in weight from 104.4 ± 4.4 kg to 99.7 ± 4.8 kg , and in waist circumference from 122.3 ± 3.2 cm to 117.0 ± 3.0 cm . Conclusions Interim results with the TANTALUS system suggest that this stimulation regime can potentially improve glucose levels and induce moderate weight loss in obese T2DM subjects on oral antidiabetic therapy with poor glycemic control . Further evaluation is required to determine whether this effect is due to induced weight loss and /or due to direct signal-dependent mechanisms This report describes the authors ’ early outcomes with implantable gastric stimulation ( IGS ) used to achieve weight loss in patients with a low body mass index ( BMI ) . After prescreening of potential c and i date s with a selection algorithm , 24 patients ( 21 women and 3 men ) with a low BMI ( 30–34.9 ) underwent IGS implantation at two centers . The patients had a mean age of 43 years ( range , 32–60 years ) , a mean BMI of 33 ( range , 30–36 ) , and a mean weight of 92 kg ( range , 80–117 kg ) . At this writing , 6 months postoperatively , there have been no serious adverse events related to the device . The mean percentage of excess weight loss ( EWL ) was 5.9 % , with three patients explanted because of noncompliance . The mean waist circumference decreased 5.8 % , which was significant ( p = 0.009 ) . A subset of nine patients ( 37.5 % ) had an EWL exceeding 10 % ( mean , 20.1 % ) . A subset of low BMI patients lost a clinical ly significant amount of weight with IGS within 6 months . Further study is required for better identification of potential c and i date s for this novel approach Obesity is one of the most prevalent health problems in the world with a lack of satisfactory therapies and gastric electrical stimulation has recently been proposed for the treatment of obesity . The aim of this study was to investigate the effects of retro grade gastric pacing ( RGP ) on food and water intake , and gastric emptying in humans .  RGP with a tachygastrial frequency of 9 cycles/min was performed via a pair of submucosal gastric electrodes implanted 5 cm above the pylorus in 12 subjects . The water load test , food intake test and scintigraphic gastric emptying test were performed to assess the efficacy of RGP . RGP result ed in a 13 % reduction in the consumption of water , a 16 % reduction in food intake and a 15 % increase in gastric retention of a solid meal . No significant symptoms were recorded with RGP using the parameters used for the water-load , food intake and scintigraphic gastric emptying tests . Acute RGP at a tachygastrial frequency results in a significant reduction of water and food intake and a delay in gastric emptying without inducing any unacceptable symptoms . It is worthy to explore its therapeutic potential for obesity Background Non-stimulatory , meal-mediated electrical stimulation of the stomach ( TANTALUS-DIAMOND ) improves glycaemic control and causes modest weight loss in patients with Type 2 diabetes who are inadequately controlled on oral anti-diabetic medications . The magnitude of the glycaemic response in clinical studies has been variable . A preliminary analysis of data from patients who had completed 6 months of treatment indicated that the glycaemic response to the electrical stimulation was inversely related to the baseline fasting plasma triglyceride level . Method An analysis of 40 patients who had had detailed longitudinal studies for 12 months . Results Twenty-two patients with fasting plasma triglycerides ≤ 1.7 mmol/l had mean decreases in HbA1c after 3 , 6 and 12 months of gastric contraction modulation treatment of −15 ± 2.1 mmol/mol ( −1.39 ± 0.20 % ) , −16 ± 2.2 mmol/mol ( −1.48 ± 0.20 % ) and −14 ± 3.0 mmol/mol ( −1.31 ± 0.26 % ) , respectively . In contrast , 18 patients with fasting plasma triglyceride > 1.7 mmol/l had mean decreases in HbA1c of −7 ± 1.7 mmol/mol ( −0.66 ± 0.16 % ) , −5 ± 1.6 mmol/mol ( −0.44 ± 0.18 % ) and −5 ± 1.7 mmol/mol ( −0.42 ± 0.16 % ) , respectively . Pearson 's correlation coefficient between fasting plasma triglyceride and decreases in HbA1c at 12 months of treatment was 0.34 ( P < 0.05 ) . Homeostasis model assessment of insulin resistance was unchanged during 12 months of treatment in patients with high baseline fasting triglycerides , while it progressively improved in patients with low fasting plasma triglycerides . Patients with low fasting plasma triglycerides had a tendency to lose more weight than those with high fasting plasma triglycerides , but this did not achieve statistical significance . Conclusions The data presented suggest the existance of a triglyceride lipotoxic mechanism that interferes with gastric/neural mediated pathways that can regulate glycaemic control in patients with type 2 diabetes . The data suggest the existence of a triglyceride lipotoxic pathway that interferes with gastric/neural mediated pathways that can regulate glycaemic control BACKGROUND To compare implantable gastric stimulation therapy with a st and ard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss ( EWL ) between the control and treatment groups . The primary endpoint was the percentage of EWL from baseline to 12 months after r and omization . Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients ; however , previous investigations have reported inconclusive results . METHODS A total of 190 subjects were enrolled in this prospect i ve , r and omized , placebo-controlled , double-blind , multicenter study . All patients underwent implantation with the implantable gastric stimulator and were r and omized to 1 of 2 treatment groups : the control group ( stimulation off ) or treatment group ( stimulation on ) . The patients were evaluated on a monthly basis . All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings . RESULTS The procedure result ed in no deaths and a low complication rate . The primary endpoint of a difference in weight loss between the treatment and control groups was not met . The control group lost 11.7 % + /- 16.9 % of excess weight and the treatment group lost 11.8 % + /- 17.6 % ( P = .717 ) according to an intent-to-treat analysis . CONCLUSION Implantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations . However , the results of the present study do not support its application . Additional research is indicated to underst and the physiology and potential benefits of this therapy Background : The TANTALUS ® System is an investigational device that consists of an implantable pulse generator connected to gastric electrodes . The system is design ed to automatically detect when eating starts and only then deliver sessions of gastric electrical stimulation ( GES ) with electrical pulses that are synchronized to the intrinsic antral slow waves . We report the effect of this type of GES on weight loss and glucose control in overweight/obese subjects with type 2 diabetes mellitus ( T2DM ) . This study was conducted under a Food and Drug Administration/Institutional Review Board-approved investigational device exemption . Method : Fourteen obese T2DM subjects on oral antidiabetes medication were enrolled and implanted laparoscopically with the TANTALUS System ( body mass index 39 ± 1 kg/m2 , hemoglobin A1c [ HbA1c ] 8.5 ± 0.2 % ) . Gastric electrical stimulation was initiated four weeks after implantation . Weight , HbA1c , fasting blood glucose , blood pressure , and lipid levels were assessed during the study period . Results : Eleven subjects reached the 6-month treatment period endpoint . Gastric electrical stimulation was well tolerated by all subjects . In those patients completing 6 months of therapy , HbA1c was reduced significantly from 8.5 ± 0.7 % to 7.6 ± 1 % , p < .01 . Weight was also significantly reduced from 107.7 ± 21.1 to 102.4 ± 20.5 kg , p < .01 . The improvement in glucose control did not correlate with weight loss ( R 2 = 0.05 , p = .44 ) . A significant improvement was noted in blood pressure , triglycerides , and cholesterol ( low-density lipoprotein only ) . Conclusions : Short-term therapy with the TANTALUS System  improves glucose control , induces weight loss , and improves blood pressure and lipids in obese T2DM subjects on oral antidiabetes therapy Background Gastric electrical stimulation ( GES ) , using the implantable TANTALUSTM System , is being explored as a treatment for obesity . The system delivers nonstimulatory electrical signals synchronized with gastric slow waves , result ing in stronger contractions . We hypothesized that this GES may enhance gastric emptying and as a result affect plasma ghrelin and insulin homeostasis . The aim was to test the effect of GES on gastric emptying of solids and on ghrelin and insulin blood levels in obese subjects . Methods The system consists of 3 pairs of gastric electrodes connected to an implantable pulse generator . Gastric emptying test  ( GE ) of solids was performed twice , on separate days , a few weeks after implantation , before and after initiation of stimulation . Blood sample s for ghrelin and insulin were taken at baseline and at 15 , 30 , 60 and 120 min after the test meal . Results There were 11 females , 1 male , mean age 39.1 ± 8.9 years , mean BMI 41.6 ± 3.4 . Data is available from 11 subjects ; GE was normal in 9 subjects and accelerated in 2 subjects  . GES significantly accelerated GE compared to control : percent retention at 2 hours 18.7 ± 12.2 vs 31.9 ± 16.4 , respectively ( P < 0.01 ) . Overall , there was no significant change in ghrelin or insulin profile after food intake . Ghrelin levels fell significantly at 60 min compared to baseline during stimulation ( P = 0.014 ) and control ( P = 0.046 ) . Conclusion GES results in a significant acceleration of gastric emptying of solids in obese subjects . GES did not have a significant effect on postpr and ial ghrelin levels when compared to control BACKGROUND A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss ( EWL ) in an initial clinical trial in obese patients . The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia , Norway , and Switzerl and . METHODS Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms . In the second trial , vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device . The patients were followed up for 6 months to assess the EWL and safety , including adverse events . 
    Output:
    