Theme 5 / GDM Outcomes and Treatment

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1 Theme 5 / GDM Outcomes and Treatment PP 35 Randomized controlled trial of a combined web-based pedometer and dietary intervention for women with previous gestational diabetes Peacock A, Bogossian F, Wilkinson SA, Gibbons K, Kim C, McIntyre HD University of Queensland and Mater Medical Research Institute, South Brisbane, Australia; University of Michigan, Ann Arbor, MI, USA Prevention of progression towards type 2 diabetes is a major health issue for women with previous gestational diabetes (GDM). In this 3 month trial, 24 women with a history of GDM 6 24 months prior to enrolment and body mass index (BMI) > 25 kg/m 2 provided informed consent and were randomly assigned to receive either usual care (UC, n=12) or an intervention (INT, n=12) consisting of (1) an internet supported pedometer program which encouraged increased physical activity through walking and (2) a nutritional coaching course consisting of an individual baseline dietary assessment and 4 group sessions informed by behavioural modification techniques. The pre-specified primary outcome was change ( ) in weight from 0 3 months. Despite multiple recruitment strategies including media involvement, recruitment proved difficult. Transport and child minding issues were most frequently cited as barriers to participation. At baseline, participant characteristics were (Mean[95%CI]): Age 37[35-39] years; Parity 3.1[2-4]; BMI 32.6[30-37] kg/m 2 and did not differ between treatment groups. At 3 month follow-up, 12 UC and 7 INT women returned and form the basis for this report. At 3 months, Mean(SD) results were as follows: Weight - INT group -2.5(2.3) kg vs. UC group +0.2(1.6) kg (p=0.009). Waist circumference INT group -3.6(4.5) cm vs. UC group -0.1(3.6)cm (p=0.07). Hip circumference - INT group -5.0(3.3) cm vs. UC group -0.2(2.6) cm (p=0.002). Glucose metabolism was assessed using fasting glucose, fasting insulin and the homeostasis model of insulin resistance (HOMA IR) as an estimate of insulin resistance. Body composition was assessed using bioimpedance methodology. None of these parameters changed significantly either between 0 3 months or between groups, although % Body Fat tended to be reduced in the INT group. This combined physical activity and dietary intervention proved effective in promoting short term weight loss in women with previous GDM and deserves consideration in larger scale studies. However, no changes in glucose metabolism or body composition were demonstrated. In this group of women with young children, recruitment into a structured lifestyle modification program proved very challenging. PP 36 Barriers to participation in a community-based lifestyle intervention programme to prevent Type 2 Diabetes following gestational diabetes mellitus O Dea A 1, Infanti JJ 1, Gibson I 2, Noctor E 1, McGuire BE 3, Glynn LG 4, Dunne FP 1, Galway Diabetes Research Centre (GDRC) NUIG 1 School of Medicine, National University of Ireland Galway, Galway, Ireland 2 Croí The West of Ireland Cardiac Foundation, Galway, Ireland 3 School of Psychology, National University of Ireland Galway, Galway, Ireland 4 Discipline of General Practice, National University of Ireland Galway, Galway, Ireland Gestational diabetes mellitus (GDM) is growing and progression to type 2 diabetes is increased sevenfold following GDM. We have designed and recruited into a community-based randomised controlled trial (RCT) of an intensive lifestyle intervention compared to standard care for delaying diabetes onset following GDM. This paper compares the clinical, anthropometric and demographic characteristics of 89 consenters versus 156 non-consenters to the RCT using data available from post-partum clinic visits following GDM. It also examines the barriers to participation in women eligible for recruitment but who

2 declined to participate. 410 women with prior GDM were invited to participate in the study; 89 consented, 156 refused, and the remainder were not contactable. Stated barriers to participation are available from the 156 non-consenters. The barriers cited by women can be grouped as follows: access/transport (distance, location, expense or lack of transportation) [n=75]; lifestyle (too busy, work schedule, caring for parents) [n=49]; parental commitments [n=48]; health-related (poor health, not concerned about health or diabetes risks, already taking action to improve health) [n=29]; research and intervention programme deterrents (research fatigue, test procedures, programme times/content) [n=26]; lack of social support [n=9]. To improve recruitment into similar programmes, researchers should consider offering home-based assessments; providing on-site child care; ensuring a variety of programme times; providing regular feedback, follow-up, and pragmatic advice for the target population. It is also important for health care providers to focus on updating and reinforcing knowledge about the future health implications of GDM. Finally, it would be valuable to integrate the use of cognitive behavioural strategies into such interventions in order to: (i) address underlying psychological barriers mitigating success in regard to behaviour change, and (ii) progress women who are still pre-contemplators in regard to lifestyle modification to the stages of contemplation and action. PP 37 Treatment of impaired glucose tolerance during pregnancy, preliminary results of a troublesome randomized study Fadl H 1,2, Gärdefors S 2, Hjertberg R 3, Nord E 4, Persson B 5, Schwarcz E 6, Åman J 1, Östlund I 2, Hanson U 1,7. 1 School of Medical health and sciences, Örebro University, Sweden; 2 Dept of Obstetrics and Gynecology, Örebro University Hospital; 3 UltraGyn, Stockholm; 4 Dept of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm; 5 MD, PhD Logbacken 2, Saltsjö- Duvnäs, Sweden; 6 Dept of Internal medicine, Örebro University Hospital; 7 Dept of Obstetrics and Gynecology, Uppsala University Hospital Previous studies suggest that treatment of IGT in pregnancy reduces fetal macrosomia. The impact of treatment on the risk of neonatal morbidity is less convincing. However, previous RCT studies have included only very mild cases of IGT. Objective: To evaluate maternal and fetal outcome in pregnant women with IGT randomized to treatment or not. Material and methods: Multicenter study in the Stockholm-Örebro area in Sweden. Patients with IGT were randomized in two groups, the study group and controls. Only singleton pregnancies with a diagnosis before completed 34 weeks were included. The diagnosis of IGT was based on results of 75g OGTT with a fasting P-glucose <7.0 mmol/l and a 2-hour P- glucose value >10. 0 and <12.2 mmol. Controls were blinded for the outcome of the OGTT and received usual prenatal care. The intervention group received dietary advice and insulin if necessary aiming to keep P-glucose fasting < 5.0 and postprandial < 6.5 mmol. The study included several primary antenatal care centers and in spite of an ambitious information program there were a lot of difficulties to recruit patients. Results: 71 patients were randomized instead of at least 200 as planned. 3 patients did not fulfill the randomization criteria and were excluded. The ITT-analysis included 32 women in the intervention group and 36 in the control group. Mean fasting and 2-h P-glucose were the same in the two groups, 5.7 and 10.7 mmol/l. There was a significant reduction in the rate of LGA (birth weight +2 SD): 6/32 vs. 14/ 36, p<0.05. The weight deviation from expected according to gestational age and sex was significantly lower in the intervention group (+8 % vs. +19 % (p<0.05). There was a tendency towards lower absolute birth weight in the intervention group (3.742 vs g p=0.15). There were no significant differences in maternal complications, gestational age, route of delivery or neonatal complications. 80% received inulin. Mean fasting P-glucose in the intervention group was 5.1 mmol/l and 65% (34-90 %) of measured P-glucose was within mmol/l. No severe hypoglycemia but P-glucose <4.0 mmol/l occurred in 0-25 % of the individual values and was related to achieved levels of P-glucose. Conclusion: This study illustrates the difficulty in recruiting patients, most likely due to a much decentralized

3 organization. As a consequence, statistical power was limited. Still, there was a reduced rate of relative birth weight in the intervention group. This is in line with previous findings and support that a reduction in birth weight is possible to achieve in spite of a more pronounced degree of glucose impairment than previously reported. Aiming to normoglycemia was associated with a high rate of mild hypoglycemia. PP 38 Gestational diabetes after Gestational diabetes Giuliani C, Bitterman O, Festa C, Rozzi V, Bianchi P 1, Mattei L, Bongiovanni M, Toscano V,Napoli A Department of Clinical and Molecular Medicine, 1 Department of Gynecological, Obstetric and Urologic Sciences, Sant'Andrea Hospital, Sapienza University, Rome, Italy Background and aims: Gestational Diabetes Mellitus (GDM) in an index pregnancy increases the risk of recurrent GDM in subsequent pregnancies. The recurrence rate of GDM has been reported to range between 30% and 84%. Factors identified as predictive of GDM recurrence include advanced maternal age, multiparity, obesity, weight gain between pregnancies, requirement of insulin therapy and macrosomia during the initial pregnancy. Although previous studies have reported important data regarding GDM recurrence rates, there are no evidences about clinical and matabolic features of GDM arising in women with prior GDM. The aim of this study was to assess GDM recurrence rates in a cohort of pregnant women with prior GDM and to compare recurrent GDM clinical and metabolic features with those of previous GDM (G1 vs G2). Materials and methods: We carried out a longitudinal observational study of the main clinical and metabolic features in 30 women (age: 32,88±4,6 yy in G1 and 36,27±4,8 yy in G2) with GDM in an index pregnancy (G1), at least a subsequent pregnancy (G2) and normal glucose tolerance in-between. GDM was diagnosed, until 2010, according to Carpenter and Coustan criteria and, from 2010, according to IADPSG criteria. Insulin resistance was defined as HOMA-IR, pancreatic function as HOMA-B% and insulin secretion as AUC IRI/AUC BG. Statistics: χ 2, Wilcoxon or p- t-test, multilevel mixed mode multivariate analysis, p<0,05. Results: GDM recurrence rate: 93,3% (n 28/30); pre-pregnancy BMI not significantly increased (22,03 (max: 33,8, min: 19,23) vs 23,05 (max: 34,79, min: 18,47) ns); pre-pregnancy BMI 30 in 12,5% (G1) vs 8,3% (G2). An earlier GDM diagnosis in G2 (24,8±6,3 vs 20,27±8,12 weeks, p=0,022) was likely to be due to an earlier first visit. G2-OGTT was found positive despite assessed 4 weeks earlier, a time during which insulin resistance was not found significantly lower (HOMA-IR: 2,19±1,15 vs 1,1±0,33, ns) as well as AUCBG/AUCIRI (0,403±0,38 in G1 vs 0,148±0,14), whilst a reduced pancreatic function was observed in G2 (HOMA-B%: 120,52±44,48 vs 102,42±40,19, p=0,018). Insulin treatment was more frequent in G2 (70,4% vs 96,3%, Χ 2 =0,011), with an earlier starting (29,37±5,7 vs 21,9±7,6 weeks, p=0,003). No worsening in maternal-neonatal outcomes was observed. Hypertension rate decreased from 26,1% to 4,3%, Χ 2 =0,04. Conclusions: High recurrence of GDM was associated with similar clinical outcome despite a slightly deteriorated pancreatic function in G2. An anticipated GDM screening is to be considered in high risk women for GDM. PP 39 Analysis of preliminary data on diabetic pregnancy outcome of mothers treated with basal insulin Lispro-Protamine compared with insulin NPH in a multicentre study in northeast of Italy Dalfrà MG 1, Filippi A 1, Soldato A 1, Moghetti P 2, Lombardi S 3, Vinci C 4, Romanelli T 5, Lapolla A 1 1 DPT of Medicine University of Padova, 2 DPT of Medicine University of Verona, 3 UO Diabetologia e Endocrinologia Azienda ULSS 5 Veneto, 4 UO Diabetologia Azienda ULSS 10 Veneto, 5 UO Diabetologia Azienda Provincia Trento

4 The occurrence of gestational diabetes or pre-gestational diabetes worsen maternal-fetal outcomes in terms of morbidity-mortality.insulin treatment could improve glycemic control and pregnancy outcome. Aim of the study is to evaluate pregnancy outcome in women affected by type 1,type2 or gestazional diabetes treated during pregnancy with Insulin LisproProtamine(L-P).606 women treated with L-P basal insulin were retrospectively evaluated and compared with a control groups(793women) treated with NPH basal insulin. The results are shown in Table1. GDM Type 1 Type2 L-P(508) NPH(125) L-P(37) NPH(504) L-P(67) NPH(164) Age (yrs) 36.3(16.2) 24.9(4.7) 35.5(4.4) 29.9(4.8) 33.2(5.6) 33.2(4.8) Prepregnancy BMI 27.2(6.0) 26.0(6.7) 24(6.0) 23.3(3.4) 28.7(5.7) 28.1(6.4) Pregnancy hypertension(%) Cesarean section(%) Birthweight (G) 3295(558) 3423(533) 3550(743) 3300(670) 3235(820) 3200(760) Macrosomia (%) Congenital malformation(%) Ketoacidosis (%) Severe hypoglycemia(%) HbA1c improved in the same way in both prepregnancy diabetic groups during pregnancy from 7.46% in preconception period to 7.1% in the 1 st trimester,6.5% in the 2 nd trimester and 6.4% in the 3 rd trimester in type 1 L-P treated diabetic mothers, from 7.5% to 7.2,7.2,6.4 in NPH group ; in type 2 women from 6.7% in preconception period to 6.4 in 1 st trimester,5.8 in the 2 nd trimester and 6.2 in the 3 rd trimester in L-P group and from 6.6% to 6.1,6.4,5.7 in NPH group. A reduction in severe hypoglycemic events and ketoacidosis in L-P treated type 1 women was found. In GDM group maternal anf fetal outcome was not different. In type 1 and type 2 L-P groups a lower frequency of cesarean Section was observed with respect to NPH: Macrosomia was not signigicant higher in type 1 L-P group with respect to NPH ones but was lower in type 2 group.conclusions: our preliminary data suggest that the use of insulin lisproprotamine to be safe and effective in pregnancy. PP 40 The pharmacological treatment of GDM: safety and efficacy of insulin Detemir Mecacci F, Biagioni S, Nardini C, Ottanelli S, Tredici Z,Serena C, Simeone S, Chiaroni R, Chiarelli S and Mello G Department of Obstetrics and Gynecology, Careggi University Hospital, Florence, Italy Previous studies have shown the importance of glucose postprandial values for fetal overgrowth. Detemir is a long-acting analog of the human insulin, it shows good pharmacokinetic characteristics in the control of basal glycaemia. Aim: To evaluate fetal and neonatal outcomes in a group of pregnant women with GDM treated with insulin analog Detemir or with Detemir and Aspart compared to a group in nutritional therapy and a control group of no GDM women. Study Design: The study included 374 women with GDM who were treated with nutritional therapy, physical activity and multiple daily injections of Detemir (Group 1) or Detemir and Aspart insulin (Group 2). The neonatal outcome was compared with a group of GDM treated only with a nutritional therapy(group 3) and a group of no GDM women (Group 4). Our goal of treatment was the achievement of glycaemic targets which mimic those found in non-diabetic pregnancies

5 (fasting, 1 and 2 hr postprandial glucose levels) in relation to the gestational age. Results: The neonatal outcome is reported in Table 1. GROUP 1. (N=109) GROUP 2. (N=160) GROUP 3. (N=105) GROUP 4. (N=474) p G.A. at birth 38.8 ± ± 2 40 ± 1 40 ± 1 n.s. AGA 86=80% 133=83% 67=64% 366=77% *G2vsG3 SGA 9=8% 9=6% 8=8% 66=14% *G2vsG4 LGA 13=12% 17=11% 30=29% 42=9% *G3vsG1,G2,G3 PI =26% 49=31% 40=38% 125=26% *G3vsG4 Birthweight 4000 g 6=6% 10=6% 13=12% 34=7% n.s. Birthweight 4500 g 0=0% 3=2% 3=3% 4=1% n.s. Mean birthweight 3252± ± ± ±371 *G3vsG2, G1 Transient neonatal hypoglycaemia ( 40 mg/dl) 22=20% 24=15% 24=23% 47=10% *G4vsG1,G3 Table 1. (* P<0.01) Conclusions: In our experience, to obtain a strong metabolic control near to that of non-diabetic women, insulin treatment need about in 30% of cases. In 41% of cases, Detemir seems to be able to control maternal diurnal and nocturnal glucose levels and to obtain postprandial physiological levels. In 59% of cases insulin Detemir need to be associated with insulin Aspart. The neonatal outcome of the treated groups seems to justify this intensive care. PP 41 Predictors of newborn and placental weight and placental ratio in women with gestational diabetes mellitus Ramos AE 1, Caimari F 1, Pujol IM 1, Garcia Petterson A 1, Ginovart G 2, Adelantado JM 3, Corcoy R 1 1 Endocrinology, Hospital Santa Creu i Sant Pau, Barcelona, Spain, 2 Pediatrics, Hospital Santa Creu i Sant Pau, Barcelona, Spain, 3 Gynecology, Hospital Santa Creu i Sant Pau, Barcelona, Spain. Background and aims: Excessive fetal growth is the most common complication in diabetic pregnancy. Placental is also disproportionately enlarged with an increment in the placental to birth weight ratio. We aimed to analyze, in women with gestational diabetes mellitus (GDM) and singleton pregnancies, the predictive ability for birth weight, placental weight and placental to birth weight ratio of acknowledged birth weight predictors. Materials and methods: Retrospective cohort study. Setting: Tertiary hospital. Diagnosis of GDM: universal screening with 50 gram oral load, National Diabetes Data Group criteria. Placental to birth weight ratio (PWBW) was defined as (placental weight/ birth weight) x100. Quantitative variables: expressed as median (P25, P75) or mean ± SD according to their distribution. In the multiple regression analyses; dependent variables were: birth weight, placental weight, PWBW. Potential predictors: maternal ethnicity, anthropometrics, smoking habit, family history of DM, personal history of prior glucose intolerance, prior pregnancy, prior macrosomia, gestational age and glucose values at GDM diagnosis, insulin treatment, mean HbA1c in the third trimester, chronic and pregnancyinduced hypertension, gestational age at delivery and fetal sex. Inclusion criteria: singleton pregnancy, GDM, delivery between 1982 and Results: We evaluated 2431 women; placental weight was available in 85.4% of deliveries. Birth weight was 3250 g (2963, 3560), placental weight 620 g (540, 720) and PWBW (17.20, 21.47). Of the 12 significant predictors of birth weight, 13 predictors of placental weight and 11 of PWBW, most were coincident. In Table 1 we display the coefficients of significant predictors of PWBW and the corresponding ones for birth weight and placental weight. Most anthropometric and metabolic parameters had a disproportionate influence on placental weight, both when promoting growth (maternal weight or 3 rd trimester HbA1c) or when restricting it (insulin treatment). However smoking habit restricted fetal growth with a disproportionate effect on the fetus. Conclusion: In women with GDM and singleton pregnancies, predictors of birth weight, placental weight and PWBW are largely concordant. The influence of different predictors has a disproportionate influence on the fetus and the placenta.

6 Coefficients of significant predictors of PWBW Predictors Birth Weight Placental Weight PWBW Maternal weight 7,973 3,174 0,043 Smoking habit -127,841-15,525 0,788 Prior history of GDM 1,318 0,022 Family history of DM 0,333 Prior pregnancy 74,623-0,351 Gestational age at diagnosis 4,596-0,031 3 hours blood glucose at diagnosis Mean HbA1c in the 3rd trimester 11,548 4,729 0,130 17,893 0,505 Insulin Treatment -17, Gestatinal age at delivery 120,433 8,718-0,492 Weight gain 20,991 6,176 0,055 PP 42 Gestational diabetes mellitus in women with multiple pregnancies. Is the metabolic abnormality milder? Caimari F, Ramos A, Pujol I, García-Patterson A, Adelantado JM, Corcoy R Hospital de la Santa Creu i Sant Pau. Barcelona, Spain Background and aims: Women with multiple pregnancies (MP) have an increased risk of gestational diabetes mellitus (GDM) vs those with singleton pregnancies (SP). We hypothesized that the underlying metabolic abnormality would be milder in women with MP. Material and methods: Retrospective cohort analysis performed in a tertiary care hospital. Women diagnosed of GDM (universal screening with a 50 g glucose oral load, NDDG criteria) and delivering between 1986 and Evaluated maternal characteristics included age, ethnicity, anthropometrics, family & personal history, gestational age & glucose values at diagnosis, HbA1c and autoimmunity. A logistic regression analysis (enter method) was performed to predict MP using the aforementioned characteristics as potential predictors. Glucose tolerance was reassessed after delivery and evaluated using Expert Committee 2003 criteria (abnormal glucose tolerance: either impaired fasting glucose, impaired glucose tolerance or diabetes mellitus). Logistic regression analysis was used to predict existence of follow-up with maternal characteristics and MP as potential predictors. Progression to abnormal glucose tolerance of women with MP vs SP was compared with Kaplan-Meier analysis. Cox regression analysis was used to analyse the predictor ability for abnormal glucose tolerance of MP after adjusting for other variables. Results: 2524 women with GDM gave birth in the period (2409 SP, 115 MP); 1511 of them (58%) were reassessed after delivery. Logistic regression analysis identified several characteristics as distinctive of MP (higher age, more frequent DM in the family, diagnosis at an earlier gestational age, lower blood glucose concentrations at diagnosis, less delay to begin treatment). MP was not a predictor of follow-up after delivery. Kaplan Meier gave a median survival to abnormal glucose tolerance of years (CI , ) in women with MP vs (CI , 7.770) in those with SP, ns. MP was not identified by Cox regression analysis as an independent predictor of abnormal glucose tolerance at follow-up. Conclusions: In the study population, women with MP had different characteristics vs those with SP without a distinct milder or worse profile. MP was not a significant predictor of abnormal glucose tolerance at follow-up.

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