Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. A randomized trial of tight vs. less tight control of mild essential and gestational hypertension in pregnancy. Evaluating the therapeutic approach in pregnancies complicated by borderline glucose intolerance: a randomized clinical trial. Impact of metabolic control of diabetes during pregnancy on neonatal hypocalcemia: a randomized study. Primary prevention of gestational diabetes mellitus and large-for-gestational-age newborns by lifestyle counseling: a cluster-randomized controlled trial. Feasibility of a lifestyle intervention in early pregnancy to prevent deterioration of glucose tolerance. A randomized controlled trial investigating the effects of a low-glycemic index diet on pregnancy outcomes in gestational diabetes mellitus. Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial.
To compare maternal glucose levels and neonatal outcome, achieved in women with gestational diabetes (GDM) receiving either regular insulin or insulin lispro, with those of a control group of non-diabetic pregnant women.
                We enrolled 49 pregnant women with GDM, randomly allocated to the treatment with either insulin lispro (n=25) or regular insulin (n=24), and 50 pregnant women with normal GCT, matched for age, parity, pre-pregnancy weight and BMI, who formed the control group. All the women were caucasian, non-obese, with a singleton pregnancy and delivered term live born infants. Women of both groups were requested to perform a blood glucose profile (consisting of nine determinations: fasting/pre-prandial, 1 and 2h post-prandial) every week from the time of diagnosis to 38 weeks (study subgroups) or every 2 weeks from 28 to 38 weeks' gestation (control group).
                Overall pre-prandial blood glucose values in diabetic women were significantly higher than those of controls; at the 1h post-prandial time point, blood glucose values of GDM women receiving insulin lispro were similar to those of controls, whereas in the regular group they were significantly higher. Overall, both the lispro and regular insulin obtained optimal metabolic control at the 2h post-prandial time point, although near-normal blood glucose levels 2h after lunch could be observed only in the lispro group. There were no statistically significant differences between the groups in neonatal outcome and anthropometric characteristics; however, the rate of infants with a cranial-thoracic circumference (CC/CT) ratio between the 10th and the 25th percentile was significantly higher in the group treated with regular insulin in comparison to the lispro and control groups.
                Fasting/pre-prandial and 1h post-prandial maternal blood glucose levels in non-diabetic pregnant women fell well below the currently accepted criteria of glycemic normality in diabetic pregnancies. In women with GDM, the use of insulin lispro enabled the attainment of near-normal glucose levels at the 1h post-prandial time point and was associated with normal anthropometric characteristics; the use of regular insulin was not able to blunt the 1h peak post-prandial response to a near-normal extent and resulted in infants with a tendency toward the disproportionate growth. Insulin lispro can be regarded as a valuable option for the treatment of gestational diabetes. The objectives of this pilot study were to determine the feasibility and effect on glycaemic control of a low-glycaemic-index (GI) diet in women with gestational diabetes or impaired glucose tolerance of pregnancy.
                participants, recruited from the Diabetes-in-Pregnancy Clinic of an inner-city teaching hospital serving a predominantly non-Caucasian population, were randomized to a low-GI (n=23) or control (n=24) diet and followed from 28 weeks gestation until delivery. Self-monitored-blood-glucose (SMBG), maternal and infant weight were collected from medical charts. Dietary intakes were assessed using diet records and questionnaires.
                diet GI on control (58, 95% CI: 56,60) was significantly higher than on low-GI (49, 95% CI: 47,51; p=0.001). Glycaemic control improved on both diets, but more postprandial glucose values were within target on low-GI (58.4% of n=1891) than control (48.7% of n=1834; p<0.001). SMBG post-breakfast was directly related to pre-pregnancy BMI in the control, but not the low-GI group (BMI*diet interaction; p=0.021). Participants accepted the study foods and were willing to consume them post-intervention.
                a low-GI diet was feasible and acceptable in this sample and facilitated control of postprandial glucose. A larger study is needed to determine the effect of a low-GI diet on maternal and infant outcomes.
                2010. Published by Elsevier Ireland Ltd. To assess the effects of applying a tight vs. a less tight control of mild chronic essential or gestational non-proteinuric hypertension in pregnancy.
                A randomized trial was conducted in 2006-2007 in the University of Ain Shams, Egypt. Eligible participants (n=125) were randomly assigned to either tight or less tight control of mild chronic (essential) or gestational (non-proteinuric) hypertension. The primary outcome measure was the development of severe hypertension during follow-up. Analysis was by intention-to-treat.
                In the tight target group, adjustment of the dose with an increment of 191 mg yielded a mean dose of methyldopa of 1267+/-406 mg. Both systolic and diastolic BP levels were significantly less than in the tight target group. More women in the less tight group had severe hypertension during follow up (RR 3.167 and 95% CI 1.36-7.37). The rate of antenatal hospitalization was significantly higher in the less tight target group with a relative risk of 2.57 and 95% CI 1.16-5.70. The gestational age at delivery was significantly better in the tight target group. Preterm delivery and birth weight were not significantly different between the study groups.
                Tight control of blood pressure reduces the rate of antenatal hospitalization and does not adversely affect perinatal outcomes in women with mild essential or gestational hypertension. Most studies relating minor gestational metabolic alterations to macrosomia refer to glucose intolerance classified on the basis of the National Diabetes Data Group or previous World Health Organization diagnostic thresholds. Our aim was to evaluate the consequences of very mild forms of gestational glucose intolerance, defined by an elevated 50-g glucose challenge test followed by a normal oral glucose tolerance test, using the more restrictive Carpenter and Coustan's criteria (Borderline Gestational Glucose Intolerance, BGGI).
                Three hundred BGGI women were randomly assigned to: Group A (standard management), Group B (dietary treatment and regular monitoring). A control group (C) was also considered. Newborns were classified as macrosomic, large (LGA), or small for gestational age (SGA).
                The three groups were similar in age, body mass index and parity. Therapy in Group B significantly improved fasting (from 4.68 +/- 0.45 to 4.28 +/- 0.45 mmol/l) and 2-h postprandial glycaemia (from 6.01 +/- 0.57 to 5.13 +/- 0.68 mmol/l). Fasting glycaemia at delivery was significantly lower in B (4.20 +/- 0.38 mmol/l) than in A (4.84 +/- 0.45 mmol/l), and was also lower than in C (4.31 +/- 0.39 mmol/l). Significantly fewer LGA babies were born to Group B (6.0%) than Group A (14.0%) and Group C (9.1%). No difference was found in the SGA rate. The neonatal Ponderal Index was higher (P = 0.030) in group A (2.73 +/- 0.35) than in C (2.64 +/- 0.30) and B (2.64 +/- 0.24).
                Even very mild alterations in glucose tolerance can result in excessive or disharmonious fetal growth, which may be prevented by simple, non-invasive therapeutic measures. To test the hypothesis that strict control of diabetes during pregnancy can reduce the risk for neonatal hypocalcemia in infants of diabetic mothers.
                One hundred thirty-seven pregnant women with insulin-dependent diabetes enrolled before 9 weeks' gestation were randomized to one of two treatment groups. In 68 subjects, the goals were fasting blood glucose level less than 4.44 mmol/L (80 mg/dL) and 1.5-hour postprandial blood glucose level less than 6.66 mmol/L (120 mg/dL) (strict control), whereas in 69 the goals were fasting blood glucose level less than 5.55 mmol/L (100 mg/dL) and 1.5-hour post-prandial glucose level less than 7.77 mmol/L (140 mg/dL) (customary control).
                Infants in the strict control group had a significantly lower rate of hypocalcemia (mean calcium less than 8.0 mg/dL in term infants and less than 7.0 mg/dL in preterm infants) than infants in the customary control group (17.6 versus 31.9%; P < .05). Using logistic regression analysis and after adjusting for the effects of gestational age, asphyxia, and White class on hypocalcemia, the difference between groups remained significant. The lowest infant serum calcium concentration correlated significantly with maternal glycohemoglobin A1 concentration at delivery (P = .03), gestational age (P = .0001), and the lowest serum magnesium concentration (P = .0001).
                Strict management of diabetes in pregnancy is associated with a reduction in the rate of neonatal hypocalcemia. Our objective was to examine whether gestational diabetes mellitus (GDM) or newborns' high birthweight can be prevented by lifestyle counseling in pregnant women at high risk of GDM.
                We conducted a cluster-randomized trial, the NELLI study, in 14 municipalities in Finland, where 2,271 women were screened by oral glucose tolerance test (OGTT) at 8-12 wk gestation. Euglycemic (n = 399) women with at least one GDM risk factor (body mass index [BMI] ≥ 25 kg/m(2), glucose intolerance or newborn's macrosomia (≥ 4,500 g) in any earlier pregnancy, family history of diabetes, age ≥ 40 y) were included. The intervention included individual intensified counseling on physical activity and diet and weight gain at five antenatal visits. Primary outcomes were incidence of GDM as assessed by OGTT (maternal outcome) and newborns' birthweight adjusted for gestational age (neonatal outcome). Secondary outcomes were maternal weight gain and the need for insulin treatment during pregnancy. Adherence to the intervention was evaluated on the basis of changes in physical activity (weekly metabolic equivalent task (MET) minutes) and diet (intake of total fat, saturated and polyunsaturated fatty acids, saccharose, and fiber). Multilevel analyses took into account cluster, maternity clinic, and nurse level influences in addition to age, education, parity, and prepregnancy BMI. 15.8% (34/216) of women in the intervention group and 12.4% (22/179) in the usual care group developed GDM (absolute effect size 1.36, 95% confidence interval [CI] 0.71-2.62, p = 0.36). Neonatal birthweight was lower in the intervention than in the usual care group (absolute effect size -133 g, 95% CI -231 to -35, p = 0.008) as was proportion of large-for-gestational-age (LGA) newborns (26/216, 12.1% versus 34/179, 19.7%, p = 0.042). Women in the intervention group increased their intake of dietary fiber (adjusted coefficient 1.83, 95% CI 0.30-3.25, p = 0.023) and polyunsaturated fatty acids (adjusted coefficient 0.37, 95% CI 0.16-0.57, p < 0.001), decreased their intake of saturated fatty acids (adjusted coefficient -0.63, 95% CI -1.12 to -0.15, p = 0.01) and intake of saccharose (adjusted coefficient -0.83, 95% CI -1.55 to -0.11, p  =  0.023), and had a tendency to a smaller decrease in MET minutes/week for at least moderate intensity activity (adjusted coefficient 91, 95% CI -37 to 219, p = 0.17) than women in the usual care group. In subgroup analysis, adherent women in the intervention group (n = 55/229) had decreased risk of GDM (27.3% versus 33.0%, p = 0.43) and LGA newborns (7.3% versus 19.5%, p = 0.03) compared to women in the usual care group.
                The intervention was effective in controlling birthweight of the newborns, but failed to have an effect on maternal GDM.
                Current Controlled Trials ISRCTN33885819. Please see later in the article for the Editors' Summary. In conjunction with the growing prevalence of obesity and the older age of pregnant women gestational diabetes (GDM) is a major health problem.The aim of the study was to evaluate if a lifestyle intervention since early pregnancy is feasible in improving the glucose tolerance of women at a high-risk for GDM in Finland.
                A 75-g oral glucose tolerance test (OGTT) was performed in early pregnancy (n = 102). Women at high risk for GDM (n = 54) were randomized at weeks 8-12 from Apr 2005 to May 2006 to a lifestyle intervention group (n = 27) or to a close follow-up group (n = 27). An OGTT was performed again at weeks 26-28 for the lifestyle intervention and close follow-up groups.
                The values of the OGTT during the second trimester did not differ between the lifestyle intervention and close follow-up groups. In the lifestyle intervention group three women had GDM in the second trimester and respectively one woman in the close follow up group. Insulin therapy was not required in both groups. The intervention resulted in somewhat lower weight gain 11.4 ± 6.0 kg vs. 13.9 ± 5.1 kg, p = 0.062, adjusted by the prepregnancy weight.
                Early intervention with an OGTT and simple lifestyle advice is feasible. A more intensive lifestyle intervention did not offer additional benefits with respect to glucose tolerance, although it tended to ameliorate the weight gain.
                ClinicalTrials.gov: NCT01130012. The prevalence of gestational diabetes mellitus (GDM) is rising. There is little evidence to demonstrate the effectiveness of one dietary therapy over another. We aimed to investigate the effect of a low-glycemic index (LGI) versus a conventional high-fiber diet on pregnancy outcomes, neonatal anthropometry, and maternal metabolic profile in GDM.
                Ninety-nine women (age 26-42 years; mean ± SD prepregnancy BMI 24 ± 5 kg/m²) diagnosed with GDM at 20-32 weeks' gestation were randomized to follow either an LGI (n = 50; target glycemic index [GI] ~50) or a high-fiber moderate-GI diet (HF) (n = 49; target GI ~60). Dietary intake was assessed by 3-day food records. Pregnancy outcomes were collected from medical records.
                The LGI group achieved a modestly lower GI than the HF group (mean ± SEM 47 ± 1 vs. 53 ± 1; P < 0.001). At birth, there was no significant difference in birth weight (LGI 3.3 ± 0.1 kg vs. HF 3.3 ± 0.1 kg; P = 0.619), birth weight centile (LGI 52.5 ± 4.3 vs. HF 52.2 ± 4.0; P = 0.969), prevalence of macrosomia (LGI 2.1% vs. HF 6.7%; P = 0.157), insulin treatment (LGI 53% vs. HF 65%; P = 0.251), or adverse pregnancy outcomes.
                In intensively monitored women with GDM, an LGI diet and a conventional HF diet produce similar pregnancy outcomes. The optimal diet for pregnancy that is complicated by excessive weight is unknown.
                We aimed to examine the effects of a low-glycemic load (low-GL) diet in overweight and obese pregnant women.
                We randomly assigned 46 overweight or obese pregnant women to receive a low-GL or a low-fat diet. Participants received carbohydrate-rich foods, fats, and snack foods through home delivery or study visits. The primary outcome was birth weight z score. Other endpoints included infant anthropometric measurements, gestational duration, maternal weight gain, and maternal metabolic parameters.
                There were no significant differences in birth weight z score or other measures of infant adiposity between groups. However, in the low-GL compared with the low-fat group, gestational duration was longer (mean ± SD: 39.3 ± 1.1 compared with 37.9 ± 3.1 wk; P = 0.05) and fewer deliveries occurred at ≤ 38.0 wk (13% compared with 48%, P = 0.02; with exclusion of planned cesarean deliveries: 5% compared with 53%; P = 0.002). Adjusted head circumference was greater in the low-GL group (35.0 ± 0.8 compared with 34.2 ± 1.3 cm, P = 0.01). Women in the low-GL group had smaller increases in triglycerides [median (interquartile range): 49 (19, 70) compared with 93 (34, 129) mg/dL; P = 0.03] and total cholesterol [13 (0, 36) compared with 33 (22, 56) mg/dL, P = 0.04] and a greater decrease in C-reactive protein [-2.5 (-5.5, -0.7) compared with -0.4 (-1.4, 1.5) mg/dL, P = 0.007].
                A low-GL diet resulted in longer pregnancy duration, greater infant head circumference, and improved maternal cardiovascular risk factors. Large-scale studies are warranted to evaluate whether dietary intervention during pregnancy aimed at lowering GL may be useful in the prevention of prematurity and other adverse maternal and infant outcomes. This trial is registered at clinicaltrials.gov as NCT00364403.
In a very limited body of evidence, few differences in outcomes were seen between very tight and tight-moderate glycaemic control targets in pregnant women with pre-existing type 1 diabetes, including actual glycaemic control achieved. There is evidence of harm (increased pre-eclampsia, caesareans and birthweights greater than 90th centile) for 'loose' control (FBG above 7 mmol/L). Future trials comparing interventions, rather than glycaemic control targets, may be more feasible particularly for pregnant women with type 2 diabetes.