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: Aims . To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome , maternal complications , additional insulin requirement , and treatment acceptability . Methods . In this r and omized , open label study , 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics .  Insulin was added to metformin treatment when required , to maintain the target glycemic control . The patients were followed up till delivery . Maternal , and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma . Results . Maternal characteristics were comparable in metformin and insulin treated group . 84.9 % patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks . Less maternal weight gain ( P < 0.001 ) and pregnancy induced hypertension ( P = 0.029 ) were observed in metformin treated group . Small for date babies were more in metformin group ( P < 0.01 ) . Neonatal hypoglycemia was significantly less and so was NICU stay of > 24 hours in metformin group ( P < 0.01 ) . Significant reduction in cost of treatment was found in metformin group . Conclusion . Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy . This trial is registered with clinical trial registration number : Clinical trials.gov NCT01855763 BACKGROUND Investigation of a possible effect of metformin on and rogen levels in pregnant women with polycystic ovary syndrome ( PCOS ) . METHODS A prospect i ve , r and omized , double-blind , placebo-controlled pilot study was conducted . Forty pregnant women with PCOS received diet and lifestyle counselling  and were r and omized to either metformin 850 mg twice daily or placebo . Primary outcome measures were changes in serum levels of dehydroepi and rosterone sulphate , and rostenedione , testosterone , sex hormone-binding globulin , and free testosterone index . Secondary outcome measures were pregnancy complications and outcome . Two-tailed t-tests and chi2-tests were used . RESULTS Maternal and rogen levels were unaffected by metformin treatment in pregnant women with PCOS . While none of the 18 women in the metformin group experienced a severe pregnancy or post-partum complication , seven of the 22 ( 32 % ) women experienced severe complications in the placebo group ( P = 0.01 ) . CONCLUSIONS Metformin treatment did not reduce maternal and rogen levels in pregnant women with PCOS . In the metformin-treated group we observed a reduction of severe , pregnancy and post-partum complications .  Metformin treatment of pregnant PCOS women may reduce complications during pregnancy and in the post-partum period Objective To determine if metformin monotherapy or metformin in combination with insulin is equally effective as insulin monotherapy at glycemic control in diabetes mellitus in pregnancy among Ghanaians . Methods This was a study involving 104 pregnant women with type 2 diabetes mellitus ( T2DM ) or gestational diabetes mellitus ( GDM ) at 20 - 30 weeks gestation . Participants were r and omized into metformin and insulin treatment groups . Starting dose of metformin was 500 mg once a day and increased gradually over two ( 2 ) weeks , to meet glycemic targets . Insulin was added if targets could not be reached on metformin alone at maximum doses . Total daily dose of premixed insulin at initiation was calculated as 0.3 IU/kg body weight and titrated upwards to achieve glycemic control . Glycemic profile monitoring was done every two weeks . Results The two hour post pr and ial blood glucose ( 2HPG ) levels were significantly lower in the metformin group than the insulin group ( p= 0.004 ) . Conclusion The findings of this study suggest that metformin monotherapy is effective in achieving glycemic targets in the management of diabetes in pregnancy . It is more effective than insulin in lowering the 2HPG level . Trial Registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) OBJECTIVE Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus ( T2DM ) . The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM . STUDY DESIGN A pilot r and omized , controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy . The primary outcome was glycemic control measured with hemoglobin A1c < 7 % at delivery . Maternal and neonatal outcomes were compared between groups . RESULTS In this study , 8 women received metformin and 11 received insulin .  All women in both groups achieved glycemic control by delivery ( HgbA1c : metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92 % ) . There were similar rates of cesarean delivery , birth weights , neonatal intensive care unit admissions , respiratory distress syndrome , and neonatal dextrose treatment between groups . There was one case of fetal macrosomia in the insulin group , one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy . CONCLUSION In this pilot study , glycemic control was achieved in women who received metformin and insulin . Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM Background . Women with polycystic ovary syndrome have elevated homocysteine levels . Elevated homocysteine levels associate with pregnancy complications . Women with polycystic ovary syndrome are often treated with metformin , a drug that may increase homocysteine levels . Hence , we investigated the effect of metformin treatment on homocysteine levels in nonpregnant and pregnant women with polycystic ovary syndrome . Methods . Two prospect i ve r and omized placebo‐controlled studies included women with polycystic ovary syndrome in a university hospital setting . Sixty‐three infertile women were treated with metformin 1,000 mg bid or placebo for 16 weeks and 38 pregnant women with metformin 850 mg bid or placebo from the first trimester and throughout pregnancy . All the women had polycystic ovary syndrome and all participants received diet and lifestyle advice , and oral folate and vitamin B12 substitution , and a daily oral multivitamin tablet . The main outcome measures were serum levels of homocysteine , folate , and vitamin B12 . Results . Serum homocysteine levels were unaffected by metformin treatment both in nonpregnant and pregnant women with polycystic ovary syndrome . However , in nonpregnant women both serum folate and vitamin B12 levels decreased with treatment . At inclusion in nonpregnant women , serum homocysteine levels associated negatively with serum levels of folate and methyl malonic acid and positively with free testosterone index . No such associations were seen in pregnant women . Conclusions . Metformin treatment in women with polycystic ovary does not increase serum homocysteine levels in the nonpregnant or the pregnant state OBJECTIVE To determine how glucose control in women with GDM treated with metformin and /or insulin  influenced  pregnancy outcomes . RESEARCH DESIGN AND METHODS Women r and omly assigned to metformin or insulin treatment in the Metformin in Gestational Diabetes ( MiG ) trial had baseline glucose tolerance test ( OGTT ) results and A1C documented , together with all capillary glucose measurements during treatment . In the 724 women who had glucose data for analysis , tertiles of baseline glucose values and A1C and of mean capillary glucose values during treatment were calculated . The relationships between maternal factors , glucose values , and outcomes ( including a composite of neonatal complications , preeclampsia , and large-for-gestational-age [ LGA ] and small-for-gestational-age infants ) were examined with bivariable and multivariate models . RESULTS Baseline OGTT did not predict outcomes , but A1C predicted LGA infants ( P = 0.003 ) . During treatment , fasting capillary glucose predicted neonatal complications ( P < 0.001 ) and postpr and ial glucose predicted preeclampsia ( P = 0.016 ) and LGA infants ( P = 0.001 ) . Obesity did not influence outcomes , and there was no interaction between glycemic control , r and omized treatment , or maternal BMI in predicting outcomes . The lowest risk of complications was seen when fasting capillary glucose was < 4.9 mmol/l ( mean ± SD 4.6 ± 0.3 mmol/l ) compared with 4.9–5.3 mmol/l or higher and when 2-h postpr and ial glucose was 5.9–6.4 mmol/l ( 6.2 ± 0.2 mmol/l ) or lower . CONCLUSIONS Glucose control in women with gestational diabetes mellitus treated with metformin and /or insulin is strongly related to outcomes . Obesity is not related to outcomes in this group . Targets for fasting and postpr and ial capillary glucose may need to be lower than currently recommended BACKGROUND We conducted a r and omized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications . METHODS We r and omly assigned women between 24 and 34 weeks ' gestation who had gestational diabetes to receive dietary advice , blood glucose monitoring , and insulin therapy as needed ( the intervention group ) or routine care . Primary outcomes included serious perinatal complications ( defined as death , shoulder dystocia , bone fracture , and nerve palsy ) , admission to the neonatal nursery , jaundice requiring phototherapy , induction of labor , cesarean birth , and maternal anxiety , depression , and health status . RESULTS The rate of serious perinatal complications was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group ( 1 percent vs. 4 percent ; relative risk adjusted for maternal age , race or ethnic group , and parity , 0.33 ; 95 percent confidence interval , 0.14 to 0.75 ; P=0.01 ) . However , more infants of women in the intervention group were admitted to the neonatal nursery ( 71 percent vs. 61 percent ; adjusted relative risk , 1.13 ; 95 percent confidence interval , 1.03 to 1.23 ; P=0.01 ) . Women in the intervention group had a higher rate of induction of labor than the women in the routine-care group ( 39 percent vs. 29 percent ; adjusted relative risk , 1.36 ; 95 percent confidence interval , 1.15 to 1.62 ; P<0.001 ) , although the rates of cesarean delivery were similar ( 31 percent and 32 percent , respectively ; adjusted relative risk , 0.97 ; 95 percent confidence interval , 0.81 to 1.16 ; P=0.73 ) . At three months post partum , data on the women 's mood and quality of life , available for 573 women , revealed lower rates of depression and higher scores , consistent with improved health status , in the intervention group . CONCLUSIONS Treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman 's health-related quality of life BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 :  metformin and glyburide vs. metformin vs. glyburide  ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8. 
    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: Aims . To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome , maternal complications , additional insulin requirement , and treatment acceptability . Methods . In this r and omized , open label study , 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics .  Insulin was added to metformin treatment when required , to maintain the target glycemic control . The patients were followed up till delivery . Maternal , and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma . Results . Maternal characteristics were comparable in metformin and insulin treated group . 84.9 % patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks . Less maternal weight gain ( P < 0.001 ) and pregnancy induced hypertension ( P = 0.029 ) were observed in metformin treated group . Small for date babies were more in metformin group ( P < 0.01 ) . Neonatal hypoglycemia was significantly less and so was NICU stay of > 24 hours in metformin group ( P < 0.01 ) . Significant reduction in cost of treatment was found in metformin group . Conclusion . Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy . This trial is registered with clinical trial registration number : Clinical trials.gov NCT01855763 BACKGROUND Investigation of a possible effect of metformin on and rogen levels in pregnant women with polycystic ovary syndrome ( PCOS ) . METHODS A prospect i ve , r and omized , double-blind , placebo-controlled pilot study was conducted . Forty pregnant women with PCOS received diet and lifestyle counselling  and were r and omized to either metformin 850 mg twice daily or placebo . Primary outcome measures were changes in serum levels of dehydroepi and rosterone sulphate , and rostenedione , testosterone , sex hormone-binding globulin , and free testosterone index . Secondary outcome measures were pregnancy complications and outcome . Two-tailed t-tests and chi2-tests were used . RESULTS Maternal and rogen levels were unaffected by metformin treatment in pregnant women with PCOS . While none of the 18 women in the metformin group experienced a severe pregnancy or post-partum complication , seven of the 22 ( 32 % ) women experienced severe complications in the placebo group ( P = 0.01 ) . CONCLUSIONS Metformin treatment did not reduce maternal and rogen levels in pregnant women with PCOS . In the metformin-treated group we observed a reduction of severe , pregnancy and post-partum complications .  Metformin treatment of pregnant PCOS women may reduce complications during pregnancy and in the post-partum period Objective To determine if metformin monotherapy or metformin in combination with insulin is equally effective as insulin monotherapy at glycemic control in diabetes mellitus in pregnancy among Ghanaians . Methods This was a study involving 104 pregnant women with type 2 diabetes mellitus ( T2DM ) or gestational diabetes mellitus ( GDM ) at 20 - 30 weeks gestation . Participants were r and omized into metformin and insulin treatment groups . Starting dose of metformin was 500 mg once a day and increased gradually over two ( 2 ) weeks , to meet glycemic targets . Insulin was added if targets could not be reached on metformin alone at maximum doses . Total daily dose of premixed insulin at initiation was calculated as 0.3 IU/kg body weight and titrated upwards to achieve glycemic control . Glycemic profile monitoring was done every two weeks . Results The two hour post pr and ial blood glucose ( 2HPG ) levels were significantly lower in the metformin group than the insulin group ( p= 0.004 ) . Conclusion The findings of this study suggest that metformin monotherapy is effective in achieving glycemic targets in the management of diabetes in pregnancy . It is more effective than insulin in lowering the 2HPG level . Trial Registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) OBJECTIVE Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus ( T2DM ) . The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM . STUDY DESIGN A pilot r and omized , controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy . The primary outcome was glycemic control measured with hemoglobin A1c < 7 % at delivery . Maternal and neonatal outcomes were compared between groups . RESULTS In this study , 8 women received metformin and 11 received insulin .  All women in both groups achieved glycemic control by delivery ( HgbA1c : metformin 5.96 ± 5.88 vs. insulin 6.34 ± 0.92 % ) . There were similar rates of cesarean delivery , birth weights , neonatal intensive care unit admissions , respiratory distress syndrome , and neonatal dextrose treatment between groups . There was one case of fetal macrosomia in the insulin group , one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy . CONCLUSION In this pilot study , glycemic control was achieved in women who received metformin and insulin . Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM Background . Women with polycystic ovary syndrome have elevated homocysteine levels . Elevated homocysteine levels associate with pregnancy complications . Women with polycystic ovary syndrome are often treated with metformin , a drug that may increase homocysteine levels . Hence , we investigated the effect of metformin treatment on homocysteine levels in nonpregnant and pregnant women with polycystic ovary syndrome . Methods . Two prospect i ve r and omized placebo‐controlled studies included women with polycystic ovary syndrome in a university hospital setting . Sixty‐three infertile women were treated with metformin 1,000 mg bid or placebo for 16 weeks and 38 pregnant women with metformin 850 mg bid or placebo from the first trimester and throughout pregnancy . All the women had polycystic ovary syndrome and all participants received diet and lifestyle advice , and oral folate and vitamin B12 substitution , and a daily oral multivitamin tablet . The main outcome measures were serum levels of homocysteine , folate , and vitamin B12 . Results . Serum homocysteine levels were unaffected by metformin treatment both in nonpregnant and pregnant women with polycystic ovary syndrome . However , in nonpregnant women both serum folate and vitamin B12 levels decreased with treatment . At inclusion in nonpregnant women , serum homocysteine levels associated negatively with serum levels of folate and methyl malonic acid and positively with free testosterone index . No such associations were seen in pregnant women . Conclusions . Metformin treatment in women with polycystic ovary does not increase serum homocysteine levels in the nonpregnant or the pregnant state OBJECTIVE To determine how glucose control in women with GDM treated with metformin and /or insulin  influenced  pregnancy outcomes . RESEARCH DESIGN AND METHODS Women r and omly assigned to metformin or insulin treatment in the Metformin in Gestational Diabetes ( MiG ) trial had baseline glucose tolerance test ( OGTT ) results and A1C documented , together with all capillary glucose measurements during treatment . In the 724 women who had glucose data for analysis , tertiles of baseline glucose values and A1C and of mean capillary glucose values during treatment were calculated . The relationships between maternal factors , glucose values , and outcomes ( including a composite of neonatal complications , preeclampsia , and large-for-gestational-age [ LGA ] and small-for-gestational-age infants ) were examined with bivariable and multivariate models . RESULTS Baseline OGTT did not predict outcomes , but A1C predicted LGA infants ( P = 0.003 ) . During treatment , fasting capillary glucose predicted neonatal complications ( P < 0.001 ) and postpr and ial glucose predicted preeclampsia ( P = 0.016 ) and LGA infants ( P = 0.001 ) . Obesity did not influence outcomes , and there was no interaction between glycemic control , r and omized treatment , or maternal BMI in predicting outcomes . The lowest risk of complications was seen when fasting capillary glucose was < 4.9 mmol/l ( mean ± SD 4.6 ± 0.3 mmol/l ) compared with 4.9–5.3 mmol/l or higher and when 2-h postpr and ial glucose was 5.9–6.4 mmol/l ( 6.2 ± 0.2 mmol/l ) or lower . CONCLUSIONS Glucose control in women with gestational diabetes mellitus treated with metformin and /or insulin is strongly related to outcomes . Obesity is not related to outcomes in this group . Targets for fasting and postpr and ial capillary glucose may need to be lower than currently recommended BACKGROUND We conducted a r and omized clinical trial to determine whether treatment of women with gestational diabetes mellitus reduced the risk of perinatal complications . METHODS We r and omly assigned women between 24 and 34 weeks ' gestation who had gestational diabetes to receive dietary advice , blood glucose monitoring , and insulin therapy as needed ( the intervention group ) or routine care . Primary outcomes included serious perinatal complications ( defined as death , shoulder dystocia , bone fracture , and nerve palsy ) , admission to the neonatal nursery , jaundice requiring phototherapy , induction of labor , cesarean birth , and maternal anxiety , depression , and health status . RESULTS The rate of serious perinatal complications was significantly lower among the infants of the 490 women in the intervention group than among the infants of the 510 women in the routine-care group ( 1 percent vs. 4 percent ; relative risk adjusted for maternal age , race or ethnic group , and parity , 0.33 ; 95 percent confidence interval , 0.14 to 0.75 ; P=0.01 ) . However , more infants of women in the intervention group were admitted to the neonatal nursery ( 71 percent vs. 61 percent ; adjusted relative risk , 1.13 ; 95 percent confidence interval , 1.03 to 1.23 ; P=0.01 ) . Women in the intervention group had a higher rate of induction of labor than the women in the routine-care group ( 39 percent vs. 29 percent ; adjusted relative risk , 1.36 ; 95 percent confidence interval , 1.15 to 1.62 ; P<0.001 ) , although the rates of cesarean delivery were similar ( 31 percent and 32 percent , respectively ; adjusted relative risk , 0.97 ; 95 percent confidence interval , 0.81 to 1.16 ; P=0.73 ) . At three months post partum , data on the women 's mood and quality of life , available for 573 women , revealed lower rates of depression and higher scores , consistent with improved health status , in the intervention group . CONCLUSIONS Treatment of gestational diabetes reduces serious perinatal morbidity and may also improve the woman 's health-related quality of life BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 :  metformin and glyburide vs. metformin vs. glyburide  ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8. 
    Output:
    