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: Objective To determine if a low glycaemic index diet in pregnancy could reduce the incidence of macrosomia in an at risk group . Design R and omised controlled trial . Setting Maternity hospital in Dublin , Irel and . Participants 800 women without diabetes , all in their second pregnancy between January 2007 to January 2011 , having previously delivered an infant weighing greater than 4 kg . Intervention Women were r and omised to receive no dietary intervention or start on a low glycaemic index diet from early pregnancy . Main outcomes The primary outcome measure was difference in birth weight . The secondary outcome measure was difference in gestational weight gain . Results No significant difference was seen between the two groups in absolute birth weight , birthweight centile , or ponderal index . Significantly less gestational weight gain occurred in women in the intervention arm ( 12.2 v 13.7 kg ; mean difference −1.3 , 95 % confidence interval −2.4 to −0.2 ; P=0.01 ) . The rate of glucose intolerance was also lower in the intervention arm : 21 % ( 67/320 ) compared with 28 % ( 100/352 ) of controls had a fasting glucose of 5.1 mmol/L or greater or a 1 hour glucose challenge test result of greater than 7.8 mmol/L ( P=0.02 ) . Conclusion A low glycaemic index diet in pregnancy did not reduce the incidence of large for gestational age  infants in a group at risk of fetal macrosomia . It did , however , have a significant positive effect on gestational weight gain and maternal glucose intolerance . Trial registration Current Controlled Trials IS RCT N54392969 Background Complex interventions in obese pregnant women should be theoretically based , feasible and shown to demonstrate anticipated behavioural change prior to inception of large r and omised controlled trials ( RCTs ) . The aim was to determine if a ) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours , and b ) to refine the intervention protocol through process evaluation of intervention fidelity . Methods We undertook a pilot RCT of a complex intervention in obese pregnant women , comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake , and increase physical activity . Subjects included 183 obese pregnant women ( mean BMI 36.3 kg/m2).Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and question naire , at 16 + 0 to 18 + 6 and at 27 + 0 to 28 + 6 weeks ’ gestation in women in control and intervention arms . Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken . The full RCT protocol was undertaken to assess feasibility . Results Compared to women in the control arm , women in the intervention arm had a significant reduction in dietary glycaemic load ( 33 points , 95 % CI −47 to −20 ) , ( p < 0.001 ) and saturated fat intake ( −1.6 % energy , 95 % CI −2.8 to −0 . 3 ) at 28 weeks ’ gestation . Objective ly measured physical activity did not change . Physical discomfort and sustained barriers to physical activity were common at 28 weeks ’ gestation . Process evaluation identified barriers to recruitment , group attendance and compliance , leading to modification of intervention delivery . Conclusions This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity , and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT .Trial registration Trial Registration Number : IS RCT Objective To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women . Design Multicentre r and omised trial . We utilised a central telephone r and omisation server , with computer generated schedule , balanced variable blocks , and stratification for parity , body mass index ( BMI ) category , and hospital . Setting Three public maternity hospitals across South Australia . Participants 2212 women with a singleton pregnancy , between 10 + 0 and 20 + 0 weeks ’ gestation , and BMI ≥25 . Interventions 1108 women were r and omised to a comprehensive dietary and lifestyle intervention delivered by research staff ; 1104 were r and omised to st and ard care and received pregnancy care according to local guidelines , which did not include such information . Main outcome measures Incidence of infants born large for gestational age ( birth weight ≥90th centile for gestation and sex ) . Prespecified secondary outcomes included birth weight > 4000 g , hypertension , pre-eclampsia , and gestational diabetes . Analyses used intention to treat principles . Results 2152 women and 2142 liveborn infants were included in the analyses . The risk of the infant being large for gestational age was not significantly different in the two groups ( lifestyle advice 203/1075 ( 19 % ) v st and ard care 224/1067 ( 21 % ) ; adjusted relative risk 0.90 , 95 % confidence interval 0.77 to 1.07 ; P=0.24 ) . Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g ( lifestyle advice 164/1075 ( 15 % ) v st and ard care 201/1067 ( 19 % ) ; 0.82 , 0.68 to 0.99 ; number needed to treat ( NNT ) 28 , 15 to 263 ; P=0.04 ) . There were no differences in maternal pregnancy and birth outcomes between the two treatment groups . Conclusions For women who were overweight or obese , the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes . Trial registration Australian and New Zeal and Clinical Trials Registry ( ACTRN12607000161426 ) OBJECTIVE To check the hypothesis that myo-inositol supplementation may reduce gestational diabetes mellitus ( GDM ) onset in pregnant women with a family history of type 2 diabetes . RESEARCH DESIGN AND METHODS A 2-year , prospect i ve , r and omized , open-label , placebo-controlled study was carried out in pregnant out patients with a parent with type 2 diabetes who were treated from the end of the first trimester with 2 g myo-inositol plus 200 µg folic acid twice a day ( n = 110 ) and in the placebo group ( n = 110 ) , who were only treated with 200 µg folic acid twice a day . The main outcome measure was the incidence of GDM in both groups . Secondary outcome measures were as follows : the incidence of fetal macrosomia ( > 4,000 g ) , gestational hypertension , preterm delivery , caesarean section , shoulder dystocia , neonatal hypoglycemia , and neonatal distress respiratory syndrome . GDM diagnosis was performed according to the International Association of the Diabetes and Pregnancy Study Groups ( IADPSG ) recommendations . RESULTS Incidence of GDM was significantly reduced in the myo-inositol group compared with the placebo group : 6 vs. 15.3 % , respectively ( P = 0.04 ) . In the myo-inositol group , a reduction of GDM risk occurrence was highlighted ( odds ratio 0.35 ) . A statistically significant reduction of fetal macrosomia in the myo-inositol group was also highlighted together with a significant reduction in mean fetal weight at delivery . In the other secondary outcome measures , there were no differences between groups . CONCLUSIONS myo-Inositol supplementation in pregnant women with a family history of type 2 diabetes may reduce GDM incidence and the delivery of macrosomia fetuses Background Mild gestational diabetes is a common complication of pregnancy , affecting up to 9 % of pregnant women . Treatment of mild GDM is known to reduce adverse perinatal outcomes such as macrosomia and associated birth injuries , such as shoulder dystocia , bone fractures and nerve palsies . This study aim ed to compare the plasma glucose concentrations and serum insulin , leptin and adiponectin in cord blood of babies of women ( a ) without gestational diabetes mellitus ( GDM ) , ( b ) with mild GDM under routine care , or ( c ) mild GDM with treatment . Methods 95 women with mild GDM on oral glucose tolerance testing ( OGTT ) at one tertiary level maternity hospital who had been recruited to the ACHOIS trial at one of the collaborating hospitals and r and omised to either Treatment ( n = 46 ) or Routine Care ( n = 49 ) and Control women with a normal OGTT ( n = 133 ) were included in the study . Women with mild GDM ( treatment or routine care group ) and OGTT normal women received routine pregnancy care . In addition , women with treated mild GDM received dietary advice , blood glucose monitoring and insulin if necessary . The primary outcome measures were cord blood concentrations of glucose , insulin , adiponectin and leptin . Results Cord plasma glucose was higher in women receiving routine care compared with control , but was normalized by treatment for mild GDM ( p = 0.01 ) . Cord serum insulin and insulin to glucose ratio were similar between the three groups . Leptin concentration in cord serum was lower in GDM treated women compared with routine care ( p = 0.02 ) and not different to control ( p = 0.11 ) . Adiponectin was lower in both mild GDM groups compared with control ( Treatment p = 0.02 and Routine Care p = 0.07 ) , while the adiponectin to leptin ratio was lower for women receiving routine care compared with treatment ( p = 0.08 ) and control ( p = 0.05 ) . Conclusion Treatment of women with mild GDM using diet , blood glucose monitoring and insulin if necessary , influences the altered fetal adipoinsular axis characteristic of mild GDM in pregnancy Please cite this paper as : Hui A , Back L , Ludwig S , Gardiner P , Sevenhuysen G , Dean H , Sellers E , McGavock J , Morris M , Bruce S , Murray R , Shen G. Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a r and omised controlled trial . BJOG 2012;119:70–77 OBJECTIVE : Emerging evidence suggests that leptin , an adipocyte-derived hormone , may have independent direct effects on both insulin secretion and action , in addition to its well documented effects on appetite and energy expenditure . Some , but not all , previously published studies suggest that maternal leptin concentrations may be increased in pregnancies complicated by gestational diabetes mellitus ( GDM ) . We examined the association between plasma leptin concentration and GDM risk . METHODS : Women were recruited before 16 weeks of gestation and were followed up until delivery .  Maternal plasma leptin concentrations  ( collected at 13 weeks of gestation ) were measured by using immunoassay . We used generalized linear models to estimate relative risks and 95 % confidence intervals . RESULTS : GDM developed in 5.7 % of the cohort ( 47 of 823 ) . Elevated leptin concentrations were positively associated with GDM risk ( P for trend < .001 ) . After adjusting for maternal prepregnancy adiposity and other confounders , women with leptin concentrations of 31.0 ng/mL or higher experienced a 4.7-fold increased risk of GDM ( 95 % confidence interval 1.2 , 18.0 ) as compared with women who had concentrations of 14.3 ng/mL or lower . We noted a strong linear component of trend in risk of GDM with increasing maternal plasma leptin concentration . Each 10-ng/mL increase in the leptin concentration was associated with a 20 % increase in GDM risk ( relative risk 1.2 ; 95 % confidence interval 1.0 , 1.3 ) . CONCLUSIONS : Hyperleptinemia , independent of maternal adiposity , in early pregnancy appears to be predictive of an increased risk of GDM later in pregnancy . Additional larger prospect i ve cohort studies are needed to confirm and more precisely assess the etiologic importance of hyperleptinemia in pregnancy . LEVEL OF EVIDENCE : BACKGROUND Although obesity in pregnancy continues to be associated with ongoing health problems , many clinicians have been reluctant to place nondiabetic , obese , pregnant women on a monitored , calorie-appropriate nutritional regimen for fear of fetal growth restriction , low birth weight , or starvation ketosis . METHODS A total of 257 patients were enrolled in the r and omized study , with a loss-to-follow-up rate of 9.73 % . Patients were assigned r and omly to either the control ( unmonitored ) group ( n=116 ) , consisting of conventional prenatal dietary management , or to the study ( monitored ) group ( n=116 ) , which was prescribed a balanced nutritional regimen and were asked to record in a diary all of the foods eaten during each day . 
    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: Objective To determine if a low glycaemic index diet in pregnancy could reduce the incidence of macrosomia in an at risk group . Design R and omised controlled trial . Setting Maternity hospital in Dublin , Irel and . Participants 800 women without diabetes , all in their second pregnancy between January 2007 to January 2011 , having previously delivered an infant weighing greater than 4 kg . Intervention Women were r and omised to receive no dietary intervention or start on a low glycaemic index diet from early pregnancy . Main outcomes The primary outcome measure was difference in birth weight . The secondary outcome measure was difference in gestational weight gain . Results No significant difference was seen between the two groups in absolute birth weight , birthweight centile , or ponderal index . Significantly less gestational weight gain occurred in women in the intervention arm ( 12.2 v 13.7 kg ; mean difference −1.3 , 95 % confidence interval −2.4 to −0.2 ; P=0.01 ) . The rate of glucose intolerance was also lower in the intervention arm : 21 % ( 67/320 ) compared with 28 % ( 100/352 ) of controls had a fasting glucose of 5.1 mmol/L or greater or a 1 hour glucose challenge test result of greater than 7.8 mmol/L ( P=0.02 ) . Conclusion A low glycaemic index diet in pregnancy did not reduce the incidence of large for gestational age  infants in a group at risk of fetal macrosomia . It did , however , have a significant positive effect on gestational weight gain and maternal glucose intolerance . Trial registration Current Controlled Trials IS RCT N54392969 Background Complex interventions in obese pregnant women should be theoretically based , feasible and shown to demonstrate anticipated behavioural change prior to inception of large r and omised controlled trials ( RCTs ) . The aim was to determine if a ) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours , and b ) to refine the intervention protocol through process evaluation of intervention fidelity . Methods We undertook a pilot RCT of a complex intervention in obese pregnant women , comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake , and increase physical activity . Subjects included 183 obese pregnant women ( mean BMI 36.3 kg/m2).Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and question naire , at 16 + 0 to 18 + 6 and at 27 + 0 to 28 + 6 weeks ’ gestation in women in control and intervention arms . Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken . The full RCT protocol was undertaken to assess feasibility . Results Compared to women in the control arm , women in the intervention arm had a significant reduction in dietary glycaemic load ( 33 points , 95 % CI −47 to −20 ) , ( p < 0.001 ) and saturated fat intake ( −1.6 % energy , 95 % CI −2.8 to −0 . 3 ) at 28 weeks ’ gestation . Objective ly measured physical activity did not change . Physical discomfort and sustained barriers to physical activity were common at 28 weeks ’ gestation . Process evaluation identified barriers to recruitment , group attendance and compliance , leading to modification of intervention delivery . Conclusions This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity , and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT .Trial registration Trial Registration Number : IS RCT Objective To determine the effect of antenatal dietary and lifestyle interventions on health outcomes in overweight and obese pregnant women . Design Multicentre r and omised trial . We utilised a central telephone r and omisation server , with computer generated schedule , balanced variable blocks , and stratification for parity , body mass index ( BMI ) category , and hospital . Setting Three public maternity hospitals across South Australia . Participants 2212 women with a singleton pregnancy , between 10 + 0 and 20 + 0 weeks ’ gestation , and BMI ≥25 . Interventions 1108 women were r and omised to a comprehensive dietary and lifestyle intervention delivered by research staff ; 1104 were r and omised to st and ard care and received pregnancy care according to local guidelines , which did not include such information . Main outcome measures Incidence of infants born large for gestational age ( birth weight ≥90th centile for gestation and sex ) . Prespecified secondary outcomes included birth weight > 4000 g , hypertension , pre-eclampsia , and gestational diabetes . Analyses used intention to treat principles . Results 2152 women and 2142 liveborn infants were included in the analyses . The risk of the infant being large for gestational age was not significantly different in the two groups ( lifestyle advice 203/1075 ( 19 % ) v st and ard care 224/1067 ( 21 % ) ; adjusted relative risk 0.90 , 95 % confidence interval 0.77 to 1.07 ; P=0.24 ) . Infants born to women after lifestyle advice were significantly less likely to have birth weight above 4000 g ( lifestyle advice 164/1075 ( 15 % ) v st and ard care 201/1067 ( 19 % ) ; 0.82 , 0.68 to 0.99 ; number needed to treat ( NNT ) 28 , 15 to 263 ; P=0.04 ) . There were no differences in maternal pregnancy and birth outcomes between the two treatment groups . Conclusions For women who were overweight or obese , the antenatal lifestyle advice used in this study did not reduce the risk delivering a baby weighing above the 90th centile for gestational age and sex or improve maternal pregnancy and birth outcomes . Trial registration Australian and New Zeal and Clinical Trials Registry ( ACTRN12607000161426 ) OBJECTIVE To check the hypothesis that myo-inositol supplementation may reduce gestational diabetes mellitus ( GDM ) onset in pregnant women with a family history of type 2 diabetes . RESEARCH DESIGN AND METHODS A 2-year , prospect i ve , r and omized , open-label , placebo-controlled study was carried out in pregnant out patients with a parent with type 2 diabetes who were treated from the end of the first trimester with 2 g myo-inositol plus 200 µg folic acid twice a day ( n = 110 ) and in the placebo group ( n = 110 ) , who were only treated with 200 µg folic acid twice a day . The main outcome measure was the incidence of GDM in both groups . Secondary outcome measures were as follows : the incidence of fetal macrosomia ( > 4,000 g ) , gestational hypertension , preterm delivery , caesarean section , shoulder dystocia , neonatal hypoglycemia , and neonatal distress respiratory syndrome . GDM diagnosis was performed according to the International Association of the Diabetes and Pregnancy Study Groups ( IADPSG ) recommendations . RESULTS Incidence of GDM was significantly reduced in the myo-inositol group compared with the placebo group : 6 vs. 15.3 % , respectively ( P = 0.04 ) . In the myo-inositol group , a reduction of GDM risk occurrence was highlighted ( odds ratio 0.35 ) . A statistically significant reduction of fetal macrosomia in the myo-inositol group was also highlighted together with a significant reduction in mean fetal weight at delivery . In the other secondary outcome measures , there were no differences between groups . CONCLUSIONS myo-Inositol supplementation in pregnant women with a family history of type 2 diabetes may reduce GDM incidence and the delivery of macrosomia fetuses Background Mild gestational diabetes is a common complication of pregnancy , affecting up to 9 % of pregnant women . Treatment of mild GDM is known to reduce adverse perinatal outcomes such as macrosomia and associated birth injuries , such as shoulder dystocia , bone fractures and nerve palsies . This study aim ed to compare the plasma glucose concentrations and serum insulin , leptin and adiponectin in cord blood of babies of women ( a ) without gestational diabetes mellitus ( GDM ) , ( b ) with mild GDM under routine care , or ( c ) mild GDM with treatment . Methods 95 women with mild GDM on oral glucose tolerance testing ( OGTT ) at one tertiary level maternity hospital who had been recruited to the ACHOIS trial at one of the collaborating hospitals and r and omised to either Treatment ( n = 46 ) or Routine Care ( n = 49 ) and Control women with a normal OGTT ( n = 133 ) were included in the study . Women with mild GDM ( treatment or routine care group ) and OGTT normal women received routine pregnancy care . In addition , women with treated mild GDM received dietary advice , blood glucose monitoring and insulin if necessary . The primary outcome measures were cord blood concentrations of glucose , insulin , adiponectin and leptin . Results Cord plasma glucose was higher in women receiving routine care compared with control , but was normalized by treatment for mild GDM ( p = 0.01 ) . Cord serum insulin and insulin to glucose ratio were similar between the three groups . Leptin concentration in cord serum was lower in GDM treated women compared with routine care ( p = 0.02 ) and not different to control ( p = 0.11 ) . Adiponectin was lower in both mild GDM groups compared with control ( Treatment p = 0.02 and Routine Care p = 0.07 ) , while the adiponectin to leptin ratio was lower for women receiving routine care compared with treatment ( p = 0.08 ) and control ( p = 0.05 ) . Conclusion Treatment of women with mild GDM using diet , blood glucose monitoring and insulin if necessary , influences the altered fetal adipoinsular axis characteristic of mild GDM in pregnancy Please cite this paper as : Hui A , Back L , Ludwig S , Gardiner P , Sevenhuysen G , Dean H , Sellers E , McGavock J , Morris M , Bruce S , Murray R , Shen G. Lifestyle intervention on diet and exercise reduced excessive gestational weight gain in pregnant women under a r and omised controlled trial . BJOG 2012;119:70–77 OBJECTIVE : Emerging evidence suggests that leptin , an adipocyte-derived hormone , may have independent direct effects on both insulin secretion and action , in addition to its well documented effects on appetite and energy expenditure . Some , but not all , previously published studies suggest that maternal leptin concentrations may be increased in pregnancies complicated by gestational diabetes mellitus ( GDM ) . We examined the association between plasma leptin concentration and GDM risk . METHODS : Women were recruited before 16 weeks of gestation and were followed up until delivery .  Maternal plasma leptin concentrations  ( collected at 13 weeks of gestation ) were measured by using immunoassay . We used generalized linear models to estimate relative risks and 95 % confidence intervals . RESULTS : GDM developed in 5.7 % of the cohort ( 47 of 823 ) . Elevated leptin concentrations were positively associated with GDM risk ( P for trend < .001 ) . After adjusting for maternal prepregnancy adiposity and other confounders , women with leptin concentrations of 31.0 ng/mL or higher experienced a 4.7-fold increased risk of GDM ( 95 % confidence interval 1.2 , 18.0 ) as compared with women who had concentrations of 14.3 ng/mL or lower . We noted a strong linear component of trend in risk of GDM with increasing maternal plasma leptin concentration . Each 10-ng/mL increase in the leptin concentration was associated with a 20 % increase in GDM risk ( relative risk 1.2 ; 95 % confidence interval 1.0 , 1.3 ) . CONCLUSIONS : Hyperleptinemia , independent of maternal adiposity , in early pregnancy appears to be predictive of an increased risk of GDM later in pregnancy . Additional larger prospect i ve cohort studies are needed to confirm and more precisely assess the etiologic importance of hyperleptinemia in pregnancy . LEVEL OF EVIDENCE : BACKGROUND Although obesity in pregnancy continues to be associated with ongoing health problems , many clinicians have been reluctant to place nondiabetic , obese , pregnant women on a monitored , calorie-appropriate nutritional regimen for fear of fetal growth restriction , low birth weight , or starvation ketosis . METHODS A total of 257 patients were enrolled in the r and omized study , with a loss-to-follow-up rate of 9.73 % . Patients were assigned r and omly to either the control ( unmonitored ) group ( n=116 ) , consisting of conventional prenatal dietary management , or to the study ( monitored ) group ( n=116 ) , which was prescribed a balanced nutritional regimen and were asked to record in a diary all of the foods eaten during each day . 
    Output:
    