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Metformin for gestational diabetes study: metformin vs insulin in gestational diabetes: glycemic control and obstetrical and perinatal outcomes: randomized prospective trial.
Picón-César, MJ, Molina-Vega, M, Suárez-Arana, M, González-Mesa, E, Sola-Moyano, AP, Roldan-López, R, Romero-Narbona, F, Olveira, G, Tinahones, FJ, González-Romero, S
American journal of obstetrics and gynecology. 2021;(5):517.e1-517.e17
Abstract
BACKGROUND Gestational diabetes that is not properly controlled with diet has been commonly treated with insulin. In recent years, several studies have published that metformin can lead to, at least, similar obstetrical and perinatal outcomes as insulin. Nevertheless, not all clinical guidelines endorse its use, and clinical practice is heterogeneous. OBJECTIVE This study aimed to test whether metformin could achieve the same glycemic control as insulin and similar obstetrical and perinatal results, with a good safety profile, in women with gestational diabetes that is not properly controlled with lifestyle changes. STUDY DESIGN The metformin for gestational diabetes study was a multicenter, open-label, parallel arms, randomized clinical trial performed at 2 hospitals in Málaga (Spain), enrolling women with gestational diabetes who needed pharmacologic treatment. Women at the age of 18 to 45 years, in the second or third trimesters of pregnancy, were randomized to receive metformin or insulin (detemir or aspart). The main outcomes were (1) glycemic control (mean glycemia, preprandial and postprandial) and hypoglycemic episodes and (2) obstetrical and perinatal outcomes and complications (hypertensive disorders, type of labor, prematurity, macrosomia, large for gestational age, neonatal care unit admissions, respiratory distress syndrome, hypoglycemia, jaundice). Outcomes were analyzed on an intention-to-treat basis. RESULTS Between October 2016 and June 2019, 200 women were randomized, 100 to the insulin-treated group and 100 to the metformin-treated group. Mean fasting and postprandial glycemia did not differ between groups, but postprandial glycemia was significantly better after lunch or dinner in the metformin-treated-group. Hypoglycemic episodes were significantly more common in the insulin-treated group (55.9% vs 17.7% on metformin; odds ratio, 6.118; 95% confidence interval, 3.134-11.944; P=.000). Women treated with metformin gained less weight from the enrollment to the prepartum visit (36-37 gestational weeks) (1.35±3.21 vs 3.87±3.50 kg; P=.000). Labor inductions (45.7% [metformin] vs 62.5% [insulin]; odds ratio, 0.506; 95% confidence interval, 0.283-0.903; P=.029) and cesarean deliveries (27.6% [metformin] vs 52.6% [insulin]; odds ratio, 0.345; 95% confidence interval, 0.187-0.625; P=.001) were significantly lower in the metformin-treated group. Mean birthweight, macrosomia, and large for gestational age and babies' complications were not different between treatment groups. The lower cesarean delivery rate for women treated with metformin was not associated with macrosomia, large or small for gestational age, or other complications of pregnancy. CONCLUSION Metformin treatment was associated with a better postprandial glycemic control than insulin for some meals, a lower risk of hypoglycemic episodes, less maternal weight gain, and a low rate of failure as an isolated treatment. Most obstetrical and perinatal outcomes were similar between groups.
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Associations between parity, pregnancy loss, and breastfeeding duration and risk of maternal type 2 diabetes: An observational cohort study.
Huo, Y, Cheng, L, Wang, C, Deng, Y, Hu, R, Shi, L, Wan, Q, Chen, L, Zeng, T, Yu, X, et al
Journal of diabetes. 2021;(11):857-867
Abstract
BACKGROUND Parity, pregnancy loss, and breastfeeding duration were found to be associated with diabetes. However, the results are inconsistent. Also, no epidemiological studies have examined the association of these reproductive factors with diabetes in the same large population. We aim to investigate the associations between parity, pregnancy loss, breastfeeding duration, and the risk of maternal diabetes in middle-aged and elderly Chinese females. METHODS We included 131 174 females aged ≥40 years from the REACTION study (Risk Evaluation of Cancers in Chinese Diabetic Individuals: A Longitudinal Study). Multivariable linear regression and logistic regression were used to assess the association between parity, pregnancy loss, and breastfeeding duration and type 2 diabetes. RESULTS The number of parities and breastfeeding duration were positively related to fasting plasma glucose, 2-hour postload glucose, glycosylated hemoglobin, and homeostatic model assessment of insulin resistance. Compared with those with one birth, nulliparous women or women with 2 or ≥3 births had a significantly increased risk of diabetes. The odds ratios (OR) and 95% confidence intervals (CI) were 1.27 (1.10-1.48), 1.17 (1.12-1.22), and 1.28 (1.21-1.35), respectively. Compared with women without pregnancy loss, those who underwent 2 (OR 1.09; 95% CI, 1.04-1.14) or ≥3 pregnancy losses (OR 1.11; 95% CI, 1.04-1.18) had an increased risk of diabetes. Moreover, women with a breastfeeding duration ≥0 to 6 months (OR 0.82; 95% CI, 0.75-0.90) and ≥6 to 12 months (OR 0.94; 95% CI, 0.89-0.99) had a significantly lower risk of diabetes. CONCLUSIONS Nulliparous women or women with multiparity or more than one pregnancy loss have an increased risk of diabetes in later life, while women who breastfeed more than 0 to 12 months have a lower risk of diabetes.
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The relationship between maternal dietary patterns during pregnancy in women with gestational diabetes mellitus and infant appetitive feeding behaviour at 6 months.
Amissah, E, Gamble, GD, Wall, CR, Crowther, CA, Harding, JE
Scientific reports. 2020;(1):20516
Abstract
Early dietary exposure may influence infant appetitive feeding behaviour, and therefore their later health. Maternal diabetes in pregnancy is associated with an increased risk of obesity in the offspring. We, therefore, examined third-trimester dietary patterns of women with gestational diabetes, their offspring's appetitive feeding behaviour at 6 months of age, and relationships between these. We used data from a prospective cohort of women with gestational diabetes and assessed maternal dietary patterns at 36 weeks' gestation using principal component analysis; infant appetitive feeding behaviour at 6 months of age using the Baby Eating Behaviour Questionnaire; and relationships between these using general linear modelling and chi-square tests. In 325 mother-infant dyads, we identified three distinct maternal dietary patterns: 'Junk,' 'Mixed,' and 'Health-conscious.' The maternal 'Health-conscious' pattern was inversely associated with 'enjoyment of food' in their sons (β - 0.24, 95% CI - 0.36 to - 0.11, p = 0.0003), but not daughters (β - 0.02, 95% CI - 0.12 to 0.08, p = 0.70), and was positively associated with 'slowness in eating,' (β 0.13, 95% CI 0.02 to 0.24, p = 0.01). Third-trimester dietary patterns in women with gestational diabetes may have sex-specific effects on infant appetitive feeding behaviour at 6 months of age.
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Effect of a lifestyle intervention during pregnancy-findings from the Finnish gestational diabetes prevention trial (RADIEL).
Rönö, K, Grotenfelt, NE, Klemetti, MM, Stach-Lempinen, B, Huvinen, E, Meinilä, J, Valkama, A, Tiitinen, A, Roine, RP, Pöyhönen-Alho, M, et al
Journal of perinatology : official journal of the California Perinatal Association. 2018;(9):1157-1164
Abstract
OBJECTIVE To assess the effect of lifestyle counseling on perinatal outcomes among women at high risk for gestational diabetes. STUDY DESIGN A total of 492 women with obesity and/or prior gestational diabetes were allocated to intervention (four sessions of lifestyle counseling, n = 249) or usual care (n = 243) before 20 weeks' gestation. RESULT Lifestyle indicators, gestational weight gain, or obstetric and perinatal outcomes did not differ between the two groups. An oral glucose tolerance test in the first half of pregnancy was pathological in 37.7% (n = 87/144) of intervention and 36.5% (n = 72/197) of control group women (p = 0.81). The total incidence of gestational diabetes diagnosed in the first or second half of pregnancy was 44.8% (107/239) in the intervention and 48.1% (111/231) in the control group (p = 0.48). CONCLUSIONS The high prevalence of impaired glucose metabolism was observed already in early pregnancy, which may have contributed to the lack of effect of the intervention.
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Maternal pre-pregnancy overweight/obesity and gestational diabetes interaction on delayed breastfeeding initiation.
Pinheiro, TV, Goldani, MZ, ,
PloS one. 2018;(6):e0194879
Abstract
BACKGROUND Cumulative evidence indicates an association between maternal overweight and gestational diabetes with delayed breastfeeding initiation; however, the presence of both conditions simultaneously has been little explored. This study aims to investigate the interaction between maternal overweight/obesity and gestational diabetes on breastfeeding initiation. METHODS This study comprises data from the IVAPSA Birth Cohort, a prospective follow-up of mothers and their newborns. Two of the five groups from IVAPSA were evaluated, considering women with and without gestational diabetes. These women were further categorized according to their pre-pregnancy body mass index as normal weight or overweight/obese. RESULTS 219 women were evaluated, 53.4% of them had pre-pregnancy overweight/obesity and 32% had gestational diabetes. Most women were able to initiate breastfeeding within 12 hours from delivery (92.7%) and only eight (3.7%) women had not breastfed in the first 24 hours postpartum. Of these, seven were overweight/obese (77.8%) and five had gestational diabetes (66.7%), with four of them having overweight/obesity and gestational diabetes concomitantly. Women with both adverse conditions had an adjusted relative risk of delayed breastfeeding initiation of 1.072 (95% CI 1.006; 1.141), p = 0.032. CONCLUSIONS The results indicate an additive interaction between maternal pre-pregnancy overweight/obesity and gestational diabetes on delayed breastfeeding initiation.
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Effectiveness of a diabetes prevention program for rural women with prior gestational diabetes mellitus: study protocol of a multi-site randomized clinical trial.
Guo, J, Tang, Y, Wiley, J, Whittemore, R, Chen, JL
BMC public health. 2018;(1):809
Abstract
BACKGROUND In China, about 53.4 million women (11%) have type 2 diabetes (T2DM). Women with prior 2 (GDM) are at a high risk for T2DM. Postpartum lifestyle interventions have been effective in reducing T2DM for this population, but the evidence is limited to interventions provided in urban areas, despite the fact that a higher prevalence of undiagnosed T2DM was found in rural areas in China. The primary purpose of this proposed study is to examine the effect of a postpartum intensive lifestyle modification (ILSM) program on physiological health outcomes (T2DM development, insulin resistance, and weight-related variables), weight-related health behaviors (dietary intake and physical activity), and psychosocial outcomes (self-efficacy, perceived stress, social support, and health-related quality of life) compared to usual care at 3, 6, and 18 months post baseline assessment. The secondary outcomes are to identify potential mediators and moderators on change of physiological health outcomes. METHODS/DESIGN A multi-site randomized clinical trial (RCT) will be conducted to examine the efficacy of an evidence-based Intensive Lifestyle Modification (ILSM) program compared with usual care for women with prior GDM living in rural areas in China. A total sample of 256 participants will be recruited in the study. The intervention consists of six bi-weekly in-person group sessions, five bi-weekly telephone consultation sessions, and three monthly telephone consultations to encourage behavior change. The usual care provided to the control group will utilize current clinical guideline and recommendations for T2DM prevention. Outcome measures include physiological variables (OGTT-2 h, HbA1c, weight, and waist circumference); weight-related health behavioral (dietary intake and physical activities); and psychosocial variables (self-efficacy and social support) at 3-, 6- and 18- month after baseline. We will also assess the potential cost-effectiveness of ILSM (net cost per T2DM case and per DALY averted) compared with usual care. DISCUSSION If successful, this ILSM program can be adapted and used in rural areas as a blueprint for clinical guidelines to decrease T2DM by improving postpartum GDM care in China. Findings of this study are expected to make a significant contribution to public health practice and health policy related to T2DM prevention in China. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1800015023 . Registered 1 March 2018 - Retrospectively registered, http://apps.who.int/trialsearch/default.aspx .
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A Tailored Letter Based on Electronic Health Record Data Improves Gestational Weight Gain Among Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster-Randomized Controlled Trial.
Hedderson, MM, Brown, SD, Ehrlich, SF, Tsai, AL, Zhu, Y, Quesenberry, CP, Crites, Y, Ferrara, A
Diabetes care. 2018;(7):1370-1377
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Abstract
OBJECTIVE Evaluate whether a tailored letter improved gestational weight gain (GWG) and whether GWG mediated a multicomponent intervention's effect on postpartum weight retention among women with gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS A cluster-randomized controlled trial of 44 medical facilities (n = 2,014 women) randomized to usual care or a multicomponent lifestyle intervention delivered during pregnancy (tailored letter) and postpartum (13 telephone sessions) to reduce postpartum weight retention. The tailored letter, using electronic health record (EHR) data, recommended an end-of-pregnancy weight goal tailored to prepregnancy BMI and GWG trajectory at GDM diagnosis: total GWG at the lower limit of the IOM range if BMI ≥18.5 kg/m2 or the midpoint if <18.5 kg/m2 and weight maintenance if women had exceeded this. The outcomes for this study were the proportion of women meeting the Institute of Medicine (IOM) guidelines for weekly rate of GWG from GDM diagnosis to delivery and meeting the end-of-pregnancy weight goal. RESULTS The tailored letter significantly increased the proportion of women meeting the IOM guidelines (72.6% vs. 67.1%; relative risk 1.08 [95% CI 1.01-1.17]); results were similar among women with BMI <25.0 kg/m2 (1.07 [1.00-1.15]) and ≥25.0 kg/m2 (1.08 [0.98-1.18]). Thirty-six percent in the intervention vs. 33.0% in usual care met the end-of-pregnancy weight goal (1.08 [0.99-1.18]); the difference was statistically significant among women with BMI <25.0 kg/m2 (1.28 [1.05-1.57]) but not ≥25.0 kg/m2 (0.99 [0.87-1.13]). Meeting the IOM guidelines mediated the effect of the multicomponent intervention in reducing postpartum weight retention by 24.6% (11.3-37.8%). CONCLUSIONS A tailored EHR-based letter improved GWG, which mediated the effect of a multicomponent intervention in reducing postpartum weight retention.
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Association between Gestational Weight Gain, Gestational Diabetes Risk, and Obstetric Outcomes: A Randomized Controlled Trial Post Hoc Analysis.
Simmons, D, Devlieger, R, van Assche, A, Galjaard, S, Corcoy, R, Adelantado, JM, Dunne, F, Desoye, G, Kautzky-Willer, A, Damm, P, et al
Nutrients. 2018;(11)
Abstract
Excess gestational weight gain (GWG) is associated with the development of gestational diabetes mellitus (GDM). Lifestyle trials have not achieved much GWG limitation, and have largely failed to prevent GDM. We compared the effect of substantial GWG limitation on maternal GDM risk. Pregnant women with a body mass index (BMI) ≥29 kg/m² <20 weeks gestation without GDM (n = 436) were randomized, in a multicenter trial, to usual care (UC), healthy eating (HE), physical activity (PA), or HE and PA lifestyle interventions. GWG over the median was associated with higher homeostasis model assessment insulin resistance (HOMA-IR) and insulin secretion (Stumvoll phases 1 and 2), a higher fasting plasma glucose (FPG) at 24⁻28 weeks (4.66 ± 0.43 vs. 4.61 ± 0.40 mmol/L, p < 0.01), and a higher rate of caesarean section (38% vs. 27% p < 0.05). The GWG over the median at 35⁻37 weeks was associated with a higher rate of macrosomia (25% vs. 16%, p < 0.05). A post hoc comparison among women from the five sites with a GWG difference >3 kg showed no significance difference in glycaemia or insulin resistance between HE and PA, and UC. We conclude that preventing even substantial increases in GWG after the first trimester has little effect on maternal glycaemia. We recommend randomized controlled trials of effective lifestyle interventions, starting in or before the first trimester.
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Effect of Physical Activity and/or Healthy Eating on GDM Risk: The DALI Lifestyle Study.
Simmons, D, Devlieger, R, van Assche, A, Jans, G, Galjaard, S, Corcoy, R, Adelantado, JM, Dunne, F, Desoye, G, Harreiter, J, et al
The Journal of clinical endocrinology and metabolism. 2017;(3):903-913
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Abstract
CONTEXT Lifestyle approaches for preventing gestational diabetes mellitus (GDM) have produced mixed results. OBJECTIVE The aim of the present study was to compare the effectiveness of 3 lifestyle interventions [healthy eating (HE), physical activity (PA), and both HE and PA (HE+PA)] with usual care (UC) in reducing GDM risk. DESIGN The present study was a multicenter randomized controlled trial conducted from 2012 to 2014 [the DALI (vitamin D and lifestyle intervention for GDM prevention) lifestyle study]. SETTING The study occurred at antenatal clinics across 11 centers in 9 European countries. PATIENTS Consecutive pregnant women at <20 weeks of gestation with a body mass index (BMI) of ≥29 kg/m2 and without GDM using the International Association of Diabetes and Pregnancy Study Group criteria (n = 436). For the intervention, women were randomized, stratified by site, to UC, HE, PA, or HE+PA. The women received 5 face-to-face and ≤4 telephone coaching sessions using the principles of motivational interviewing. A gestational weight gain (GWG) <5 kg was targeted. The coaches received standardized training and an intervention toolkit tailored to their culture and language. MAIN OUTCOME MEASURES The endpoints were the GWG at 35 to 37 weeks and the fasting glucose and insulin sensitivity [homeostasis model assessment insulin resistance (HOMA-IR)] at 24 to 28 weeks. RESULTS We randomized 108 women to HE+PA, 113 to HE, 110 to PA, and 105 to UC. In the HE+PA group, but not HE or PA alone, women achieved substantially less GWG than did the controls (UC) by 35 to 37 weeks (-2.02; 95% confidence interval, -3.58 to -0.46 kg). Despite this reduction, no improvements were seen in fasting or postload glucose levels, insulin concentrations, or HOMA-IR. The birthweights and large and small for gestational age rates were similar. CONCLUSIONS The combined HE+PA intervention was able to limit GWG but did not reduce fasting glycemia. Thus, lifestyle changes alone are unlikely to prevent GDM among women with a BMI of ≥29 kg/m2.
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Free Thyroxine During Early Pregnancy and Risk for Gestational Diabetes.
Haddow, JE, Craig, WY, Neveux, LM, Palomaki, GE, Lambert-Messerlian, G, Malone, FD, D'Alton, ME, ,
PloS one. 2016;(2):e0149065
Abstract
Several studies have now reported associations between gestational diabetes mellitus (GDM) and low free thyroxine (fT4) during the second and third trimesters, but not in the first trimester. The present study further examines relationships between low fT4, maternal weight, and GDM among women in the FaSTER (First and Second Trimester Evaluation of Risk) trial, in an effort to determine the extent to which thyroid hormones might contribute to causality. The FaSTER cohort includes 9351 singleton, euthyroid women; 272 of these women were subsequently classified as having GDM. Thyrotropin (TSH), fT4, and thyroid antibodies were measured at 11-14 weeks' gestation (first trimester) and 15-18.9 weeks' gestation (second trimester). An earlier report of this cohort documented an inverse relationship between fT4 in the second trimester and maternal weight. In the current analysis, women with GDM were significantly older (32 vs. 28 years) and weighed more (75 vs. 64.5 kg). Maternal weight and age (but not TSH) were significantly associated univariately with fT4 (dependent variable), in the order listed. Second trimester fT4 odds ratios (OR) for GDM were 2.06 [95% CI 1.37-3.09] (unadjusted); and 1.89 [95% CI 1.26-2.84] (adjusted). First trimester odds ratios were not significant: OR 1.45 [95%CI 0.97-2.16] (unadjusted) and 1.11 [95% CI 0.74-1.62] (adjusted). The second trimester fT4/GDM relationship thus appeared to strengthen as gestation progressed. In FaSTER, high maternal weight was associated with both low fT4 and a higher GDM rate in the second trimester. Peripheral deiodinase activity is known to increase with high caloric intake (represented by high weight). We speculate that weight-related low fT4 (the metabolically inactive prohormone) is a marker for deiodinase activity, serving as a substrate for conversion of fT4 to free triiodothyronine (fT3), the active hormone responsible for glucose-related metabolic activity.