To examine the impact of a prepregnancy very-low-energy diet (VLED) program on time to pregnancy in women with obesity.
Substudy of a two-arm parallel group randomized controlled trial.
Multiple ...tertiary care centers.
Women 18–38 years old with obesity (body mass index 30–55 kg/m2) and planning conception.
One hundred sixty-four normoglycemic women with body mass index 30–55 kg/m2, aged 18–38 years, and planning pregnancy were recruited through a social media platform for a two-arm randomized controlled trial. Women were allocated to a 12-week standard dietary intervention (SDI) or modified VLED. Completers of the intervention were observed for up to 48 weeks, and time to pregnancy was recorded.
The prespecified exploratory outcome for this substudy was time to pregnancy between the completion of the 12-week intervention and the date of conception.
Maternal weight loss at the end of the 12-week intervention was 3.1% in the SDI group and 11.9% in the VLED group. In completers of the 12-week intervention, time to pregnancy was significantly shorter in the women allocated to the VLED group than in the SDI group. Post hoc analysis showed that this difference in time to conception was particularly overt within 90 days of the intervention.
A VLED program that achieves substantial weight loss before conception reduces time to pregnancy compared with an SDI in women with obesity.
ACTRN12614001160628.
El tiempo en conseguir el embarazo después de un programa pregestacional, con una dieta muy baja en calorías en mujeres con obesidad: sub estudio de un ensayo controlado aleatorio.
Examinar el impacto de un programa de una dieta muy baja en calorías (VLED) en el tiempo para conseguir el embarazo en mujeres con obesidad.
Sub estudio de un ensayo controlado aleatorio de dos grupos en paralelo.
Múltiples centros de atención terciaria.
Mujeres de 18-38 años con obesidad (índice de masa corporal 30 a 55 kg / m2) y que han planificado concebir.
Se reclutaron ciento sesenta y cuatro mujeres normo glucémicas con índice de masa corporal de 30 a 55 kg / m2, de 18 a 38 años y que planeaban un embarazo, a través de una plataforma de redes sociales para un ensayo controlado aleatorio de dos grupos. Las mujeres fueron asignadas a una intervención dietética estándar (SDI) de 12 semanas o VLED modificado. Se observó a quienes completaron la intervención hasta 48 semanas y se registró el tiempo hasta conseguir el embarazo.
El resultado exploratorio preespecifico para este sub estudio fue el tiempo transcurrido hasta el embarazo, entre la finalización de la intervención a las 12 semanas y la fecha de la concepción.
La pérdida de peso materno al final de la intervención a las 12 semanas fue del 3,1% en el grupo de SDI y del 11,9% en el grupo de VLED. En aquellos casos que completaron la intervención de 12 semanas, el tiempo hasta el embarazo fue significativamente más corto en las mujeres asignadas al grupo VLED que en el grupo SDI. El análisis post hoc mostró que esta diferencia en el tiempo hasta la concepción fue particularmente evidente dentro de los 90 días posteriores a la intervención.
Un programa VLED en el que se logra una pérdida de peso sustancial antes de la concepción, reduce el tiempo en que se consigue el embarazo, en comparación con un SDI, en mujeres con obesidad.
Objective
This study examined the effectiveness of a nonsurgical, preconception weight loss intervention on pregnancy outcomes in women with obesity.
Methods
This was a two‐arm, parallel‐group ...randomized controlled trial. A total of 164 women with BMI 30 to 55 kg/m2 who were aged 18 to 38 years and planning pregnancy were randomized to a 12‐week standard dietary intervention (SDI; n = 79) or a modified very low‐energy diet (VLED; n = 85). Participants were observed for ≤48 weeks while trying for pregnancy and then during pregnancy. The primary outcome was maternal fasting plasma glucose at 26 to 28 weeks’ gestation. Exploratory outcomes were individual and composite obesity‐related adverse pregnancy outcomes.
Results
Weight loss was greater in the VLED group (SDI 3.2 0.6 kg vs. VLED 13.0 0.5 kg, p < 0.01). In completers who had a singleton live birth (SDI 22/79 vs. VLED 35/85, p = 0.10), there was no difference in fasting glucose at 26 to 28 weeks’ gestation (SDI 4.80.2 mmol/L vs. VLED 4.6 0.1 mmol/L, p = 0.42). However, the composite of adverse pregnancy outcomes was significantly lower in the VLED group (p < 0.001).
Conclusions
Substantial prepregnancy weight loss in women with obesity does not alter fasting glucose at 26 to 28 weeks’ gestation but does reduce a composite of adverse pregnancy outcomes. A better understanding of metabolic changes in pregnancy after preconception weight loss may assist in improving maternal and neonatal health outcomes.
To investigate if early electronic identification and bedside management of inpatients with diabetes improves glycemic control in noncritical care.
We investigated a proactive or early intervention ...model of care (whereby an inpatient diabetes team electronically identified individuals with diabetes and aimed to provide bedside management within 24 h of admission) compared with usual care (a referral-based consultation service). We conducted a cluster randomized trial on eight wards, consisting of a 10-week baseline period (all clusters received usual care) followed by a 12-week active period (clusters randomized to early intervention or usual care). Outcomes were adverse glycemic days (AGDs) (patient-days with glucose <4 or >15 mmol/L <72 or >270 mg/dL) and adverse patient outcomes.
We included 1,002 consecutive adult inpatients with diabetes or new hyperglycemia. More patients received specialist diabetes management (92% vs. 15%,
< 0.001) and new insulin treatment (57% vs. 34%,
= 0.001) with early intervention. At the cluster level, incidence of AGDs decreased by 24% from 243 to 186 per 1,000 patient-days in the intervention arm (
< 0.001), with no change in the control arm. At the individual level, adjusted number of AGDs per person decreased from a mean 1.4 (SD 1.6) to 1.0 (0.9) days (-28% change 95% CI -45 to -11,
= 0.001) in the intervention arm but did not change in the control arm (1.8 2.0 to 1.5 1.8, -9% change -25 to 6,
= 0.23). Early intervention reduced overt hyperglycemia (55% decrease in patient-days with mean glucose >15 mmol/L,
< 0.001) and hospital-acquired infections (odds ratio 0.20 95% CI 0.07-0.58,
= 0.003).
Early identification and management of inpatients with diabetes decreased hyperglycemia and hospital-acquired infections.
Abstract Background Diabetic retinopathy (DR) may worsen during pregnancy, but its course in the postpartum remains poorly understood. Understanding the natural history of DR during and after ...pregnancy can help determine when sight‐threatening DR treatment should be administered. Methods A prospective longitudinal cohort study recruited pregnant women with pre‐existing type 1 (T1D) or type 2 diabetes from two tertiary Diabetes Antenatal Clinics in Melbourne, Australia. Eye examination results in early pregnancy, late pregnancy, and up to 12‐months postpartum were compared to determine DR changes. Two‐field fundus photographs and optical coherence tomography scans were used to assess DR severity. Results Overall, 105 (61.4%) women had at least two eye examinations during the observation period. Mean age was 33.5 years (range 19–51); 54 women (51.4%) had T1D; 63% had HbA1c <7% in early pregnancy. DR progression rate was 23.8% (95% CI 16.4–32.6). Having T1D (RR 4.96, 95% CI 1.83–13.46), pre‐existing DR in either eye (RR 4.54, 95% CI 2.39–8.61), and elevated systolic blood pressure (adjusted RR 2.49, 95% CI 1.10–5.66) were associated with increased risk of progression. Sight‐threatening progression was observed in 9.5% of women. Among the 19 eyes with progression during pregnancy, 15 eyes remained stable, three eyes progressed, and only one eye regressed in the postpartum. Conclusions Nearly 1 in 4 women had DR progression from conception through to 12‐months postpartum; almost half of these developing sight‐threatening disease. DR progression occurring during pregnancy was found to predominantly remain unchanged, or worsen, after delivery, with very few eyes spontaneously improving postpartum.
Background
Diabetic retinopathy (DR) may be affected by pregnancy. The majority of prevalence data regarding DR in pregnancy predate the advent of contemporary guidelines for diabetes management ...during pregnancy. This study reports DR prevalence and associated risk factors in women with pregestational diabetes during pregnancy and the postpartum in Australia.
Methods
A total of 172 pregnant women with type 1 (T1DM) or type 2 diabetes diagnosed pre‐pregnancy were prospectively recruited from two obstetrics hospitals in Melbourne (November 2017–March 2020). Eye examinations were scheduled in each trimester, at 3‐, 6‐, and 12‐months postpartum. DR severity was graded from two‐field fundus photographs by an independent grader utilising the Airlie House Classification. Sight‐threatening DR (STDR) was defined as the presence of diabetic macular oedema or proliferative DR.
Results
Overall, 146 (84.9%) women had at least one eye examination during pregnancy. The mean age was 33.8 years (range 19–51), median diabetes duration was 7.0 years (IQR 3.0–17.0), 71 women (48.6%) had T1DM. DR and STDR prevalence during pregnancy per 100 eyes was 24.3 (95% CI 19.7–29.6) and 9.0 (95% CI 6.1–12.9); while prevalence in the postpartum was 22.2 (95% CI 16.5–29.3) and 10.0 (95% CI 5.4–17.9), respectively. T1DM, longer diabetes duration, higher HbA1c in early pregnancy, and pre‐existing nephropathy were significant risk factors.
Conclusions
The prevalence of DR in pregnant women was similar to the non‐pregnant diabetic population in Australia. One in nine participants had STDR during pregnancy and the postpartum, highlighting the need to optimise DR management guidelines in pregnancy given the significant risk of vision loss.
Aims. We aimed to determine whether plasma advanced glycation end products or oxidation products (AGE/oxidation-P) predict altered renal function and/or preeclampsia (PE) in pregnant women with type ...1 diabetes. Methods. Prospectively, using a nested case-control design, we studied 47 pregnant women with type 1 diabetes, of whom 23 developed PE and 24 did not. Nineteen nondiabetic, normotensive pregnant women provided reference values. In plasma obtained at ~12, 22, and 32 weeks’ gestation (visits 1, 2, and 3; V1-V3), we measured five AGE products (carboxymethyllysine (CML), carboxyethyl-lysine (CEL), methylglyoxal-hydroimidazolone (MGH1), 3-deoxyglucosone hydroimidazolone (3DGH), and glyoxal-hydroimidazolone (GH1)) and four oxidation products (methionine sulfoxide (MetSO), 2-aminoadipic acid (2-AAA), 3-nitrotyrosine (3NT), and dityrosine (DT)), by liquid chromatography/mass spectroscopy. Clinical outcomes were “estimated glomerular filtration rate” (eGFR) at each visit and onset of PE. Results. In diabetic women, associations between AGE/oxidation-P and eGFR were found only in those who developed PE. In this group, CEL, MGH1, and GH1 at V2 and CML, CEL, MGH1, and GH1 at V3 were inversely associated with contemporaneous eGFR, while CEL, MGH1, 3DGH, and GH1 at V2 were inversely associated with eGFR at V3 (all p<0.05). There were no associations of plasma AGE or oxidation-P with pregnancy-related development of proteinuria or PE. Conclusions. Inverse associations of second and early third trimester plasma AGE with eGFR among type 1 diabetic women who developed PE suggest that these patients constitute a subset susceptible to AGE-mediated injury and thus to cardiorenal complications later in life. However, AGE/oxidation-P did not predict PE in type 1 diabetic women.
The risk for preeclampsia (PE) is enhanced ~4-fold by the presence of maternal type 1 diabetes (T1DM). Vitamin D is essential for healthy pregnancy. We assessed the total, bioavailable, and free ...concentrations of plasma 25-hydroxyvitamin D (25(OH)D), 1,25-dihydroxyvitamin D (1,25(OH)
D), and vitamin D binding protein (VDBP) at ~12, ~22, and ~32 weeks' gestation ("Visits" (V) 1, 2, and 3, respectively) in 23 T1DM women who developed PE, 24 who remained normotensive, and 19 non-diabetic, normotensive women (reference controls). 25(OH)D deficiency was more frequent in diabetic than non-diabetic women (69% vs. 22%,
< 0.05), but no measure of 25(OH)D predicted PE. By contrast, higher 1,25(OH)
D concentrations at V2 (total, bioavailable, and free:
< 0.01) and V3 (bioavailable:
< 0.05; free:
< 0.01), lower concentrations of VDBP at V3 (
< 0.05), and elevated ratios of 1,25(OH)
D/VDBP (V2, V3:
< 0.01) and 1,25(OH)
D/25(OH)D (V3,
< 0.05) were all associated with PE, and significance persisted in multivariate analyses. In summary, in women with T1DM, concentrations of 1,25(OH)
D were higher, and VDBP lower, in the second and third trimesters in women who later developed PE than in those who did not. 1,25(OH)
D may serve as a new marker for PE risk and could be implicated in pathogenesis.
Abstract
Context
The incidence of preeclampsia (PE) is increased in women with diabetes (∼20% vs ∼5% in the general population), and first trimester lipoprotein profiles are predictive. Haptoglobin ...(Hp), a protein with functional genetic polymorphisms, has antioxidant, anti-inflammatory, and angiogenic effects. Among people with diabetes, the Hp 2-2 phenotype is associated with cardiorenal disease.
Objective
To investigate whether Hp phenotype is associated with PE in type 1 diabetes mellitus (T1DM) and/or modulates lipoprotein-associated risks.
Design and Setting
Multicenter prospective study of T1DM pregnancy.
Patients
Pregnant women with T1DM (normal albuminuria, normotensive at enrolment, n = 47) studied at three visits, all preceding PE onset: 12.3 ± 1.9, 21.8 ± 1.5, and 31.5 ± 1.6 weeks’ gestation (mean ± SD).
Main Outcome Measures
Hp phenotype and lipoprotein profiles in women with (n = 23) vs without (n = 24) subsequent PE.
Results
Hp phenotype did not predict PE, but lipoprotein associations with subsequent PE were confined to women with Hp 2-2, in whom the following associations with PE were observed: increased low-density lipoprotein (LDL) cholesterol, LDL particle concentration, apolipoprotein B (APOB), triacylglycerol/high-density lipoprotein (HDL) cholesterol ratio, and APOB/apolipoprotein AI (APOA1) ratio; decreased HDL cholesterol, APOA1, large HDL particle concentration, and peripheral lipoprotein lipolysis (all P < 0.05). In women with one or two Hp-1 alleles, no such associations were observed.
Conclusions
In women with T1DM, although Hp phenotype did not predict PE risk, lipoprotein-related risks for PE were limited to those with the Hp 2-2 phenotype. Hp phenotype may modulate PE risk in diabetes.
The association of adverse lipoprotein profiles with preeclampsia in women with type 1 diabetes may depend entirely on those with the haptoglobin 2-2 phenotype.
This study was conducted to determine the utility of tubular (urinary/plasma neutrophil gelatinase-associated lipocalin NGAL and urinary kidney injury molecule 1 KIM-1) and glomerular (estimated ...glomerular filtration rate eGFR) biomarkers in predicting preeclampsia (PE) in pregnant women with type 1 diabetes mellitus (T1DM) who were free of microalbuminuria and hypertension at the first trimester.
This was a prospective study of T1DM pregnancy. Maternal urinary and plasma NGAL, urinary KIM-1 (ELISA of frozen samples), and eGFR (Chronic Kidney Disease Epidemiology Collaboration equation) were determined at three study visits (V1: 12.4 ± 1.8; V2: 21.7 ± 1.4; V3: 31.4 ± 1.5 weeks' gestation mean ± SD) in 23 women with T1DM with subsequent PE (DM+PE+), 24 who remained normotensive (DM+PE-), and, for reference, in 19 normotensive pregnant women without diabetes (DM-). The groups with diabetes were matched for age, diabetes duration, and parity. All subjects were normotensive and free of microalbuminuria or albuminuria at V1. All study visits preceded the onset of PE.
Urinary creatinine-corrected NGAL (uNGALcc, ng/mg) was significantly elevated at V1 in DM+PE+ vs. DM+PE- women (
= 0.01); this remained significant after exclusion of leukocyte-positive samples (5 DM+PE+ and 2 DM+PE-) (
= 0.02). Accounting for BMI, HbA
, and total daily insulin dose, a doubling of uNGALcc at V1 conferred a sevenfold increase in risk for PE (
= 0.026). In contrast, neither plasma NGAL nor urinary KIM-1 predicted PE. Also at V1, eGFR was elevated in DM+PE+ vs. DM+PE- (
= 0.04).
Early tubular and glomerular dysfunction may predict PE in first trimester women with T1DM, even if free of microalbuminuria. These data suggest that subclinical renal tubular and glomerular injury, if present early in pregnancy, may predispose women with T1DM to PE.
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