The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial

Ibrahim, Moustafa I.; Hamdy, Ahmed; Shafik, Adel; Taha, Salah Ali; Anwar, Mohammed Moustapha; Faris, M. A.

doi:10.1007/s00404-013-3090-7

Cited by 44 publications

(49 citation statements)

References 24 publications

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“…We considered α to be 0.05 and chose a power of 95% (β = 0.05), in order to minimize the risk of type II error. The sample size was calculated according to the following equation, a drop‐out rate of 10% was anticipated (slightly higher than the 8.7% rate previously published from our hospital):

normalN = normalK \times normalD \times (() [{normalp}_{1} \times (1 - {normalp}_{1})] + ([], p_{2} \times ((), 1 - p_{2}))) true/ {({normalp}_{1} - {normalp}_{2})}^{2}

…”

Section: Methodssupporting

confidence: 92%

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Identification of metformin poor responders, requiring supplemental insulin, during randomization of metformin versus insulin for the control of gestational diabetes mellitus

Ashoush

El-Said

Fathi

et al. 2016

J of Obstet and Gynaecol

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normalN = normalK \times normalD \times (() [{normalp}_{1} \times (1 - {normalp}_{1})] + ([], p_{2} \times ((), 1 - p_{2}))) true/ {({normalp}_{1} - {normalp}_{2})}^{2}

…”

Section: Methodssupporting

confidence: 92%

“…study, and 76.1% in the Ibrahim et al . study . Therefore the aim of this study was to determine whether metformin with or without supplemental insulin may be as effective as insulin in controlling blood glucose.…”

Section: Methodsmentioning

confidence: 98%

Identification of metformin poor responders, requiring supplemental insulin, during randomization of metformin versus insulin for the control of gestational diabetes mellitus

Ashoush

El-Said

Fathi

et al. 2016

J of Obstet and Gynaecol

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“…In addition, we did not assess the effects of calcium and vitamin D supplementation on pregnancy outcomes. However, earlier studies have shown that admissions to neonatal intensive care units were significantly reduced when maternal glycaemic control improved [8]. In addition, management of inflammation through administration of anti-inflammatory drugs during pregnancy significantly regulated ambulatory blood pressure and reduced the incidence of pre-eclampsia, gestational hypertension, preterm delivery and intrauterine growth retardation [39].…”

Section: Discussionmentioning

confidence: 99%

“…Current therapies for GDM include a low-glycaemic index diet, carbohydrate restriction [7], the use of some oral hypoglycaemic agents [8] and insulin therapy [9]. A few recent studies have shown that supplementation with calcium [10] and vitamin D [11] in patients with GDM might affect pregnancy outcomes.…”

Section: Introductionmentioning

confidence: 99%

Effects of calcium–vitamin D co-supplementation on glycaemic control, inflammation and oxidative stress in gestational diabetes: a randomised placebo-controlled trial

2014

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Aims/hypothesis This study was designed to assess the effects of calcium and vitamin D supplementation on the metabolic status of pregnant women with gestational diabetes mellitus (GDM). Methods This randomised placebo-controlled trial was performed at maternity clinics affiliated to Kashan University of Medical Sciences, Kashan, Iran. Participants were 56 women with GDM at 24-28 weeks' gestation (18 to 40 years of age). Subjects were randomly assigned to receive calcium plus vitamin D supplements or placebo. All study participants were blinded to group assignment. Individuals in the calcium-vitamin D group (n=28) received 1,000 mg calcium per day and a 50,000 U vitamin D 3 pearl twice during the study (at study baseline and on day 21 of the intervention), and those in the placebo group (n=28) received two placebos at the mentioned times. Fasting blood samples were taken at study baseline and after 6 weeks of intervention. Results The study was completed by 51 participants (calcium-vitamin D n=25, placebo n=26). However, as the analysis was based on an intention-to-treat approach, all 56 women with GDM (28 in each group) were included in the final analysis. After the administration of calcium plus vitamin D supplements, we observed a significant reduction in fasting plasma glucose (−0.89 ± 0.69 vs +0.26 ± 0.92 mmol/l, p<0.001), serum insulin levels (−13.55±35.25 vs +9.17± 38.50 pmol/l, p=0.02) and HOMA-IR (−0.91±1.18 vs + 0.63±2.01, p=0.001) and a significant increase in QUICKI (+0.02 ±0.03 vs −0.002 ±0.02, p= 0.003) compared with placebo. In addition, a significant reduction in serum LDL-cholesterol (−0.23±0.79 vs +0.26±0.74 mmol/l, p= 0.02) and total cholesterol: HDL-cholesterol ratio (−0.49± 1.09 vs +0.18±0.37, p=0.003) and a significant elevation in HDL-cholesterol levels (+0.15±0.25 vs −0.02±0.24 mmol/l, p=0.01) was seen after intervention in the calcium-vitamin D group compared with placebo. In addition, calcium plus vitamin D supplementation resulted in a significant increase in GSH (+51.14±131.64 vs −47.27±203.63 μmol/l, p=0.03) and prevented a rise in MDA levels (+0.06±0.66 vs +0.93± 2.00 μmol/l, p=0.03) compared with placebo. Conclusions/interpretation Calcium plus vitamin D supplementation in women with GDM had beneficial effects on their metabolic profile.

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“…Metformin was associated with fewer hypertensive disorders of pregnancy but more small for gestational age infants 61. An additional study by Ibrahim and colleagues of 90 women with gestational diabetes or type 2 diabetes found that the addition of metformin to insulin reduced the risk of neonatal hypoglycemia 60. Several ongoing RCTs comparing metformin with placebo in women with either type 2 diabetes or early onset gestational diabetes receiving insulin (Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD), NCT02932475; and Metformin in Women With Type 2 Diabetes in Pregnancy Trial (MiTy), NCT01353391) will provide useful information on the effect of metformin as adjuvant therapy in this population, particularly with regard to the possible reduction in pre-eclampsia rates 67…”

Section: Metforminmentioning

confidence: 99%

Novel therapies for diabetes mellitus in pregnancy

Feghali

Scifres

2018

BMJ

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Diabetes is a common complication of pregnancy, and the prevalence of all types of the disease is increasing worldwide. Diabetes in pregnancy is associated with short term and long term adverse effects for mother and child. The goal of treatment of diabetes in pregnancy is to minimize maternal and fetal adverse events related to hyperglycemia. Treatment options vary by type of diabetes, from a focus on lifestyle modifications in gestational diabetes to continuous glucose monitoring and insulin pumps in pregestational diabetes. Nevertheless, given the commonality of hyperglycemia, considerable overlap exists in the treatment of different types of diabetes in pregnancy. Also, despite ongoing research on treatment of diabetes in pregnancy for decades, changes in the characteristics of the patient population have highlighted the limited effectiveness of different therapies. Specifically, despite the co-occurrence of obesity and diabetes, treatment recommendations including glycemic targets are not altered in such cases and a single optimal treatment strategy for each type of diabetes in pregnancy does not seem to exist. Rather, the approach to treating pregnant women with diabetes likely needs to be individualized to maximize the short term and long term health of mother and child. This article will review recent clinical studies to summarize established treatment strategies and introduce novel therapies for diabetes in pregnancy.

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The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial

Cited by 44 publications

References 24 publications

Identification of metformin poor responders, requiring supplemental insulin, during randomization of metformin versus insulin for the control of gestational diabetes mellitus

Identification of metformin poor responders, requiring supplemental insulin, during randomization of metformin versus insulin for the control of gestational diabetes mellitus

Effects of calcium–vitamin D co-supplementation on glycaemic control, inflammation and oxidative stress in gestational diabetes: a randomised placebo-controlled trial

Novel therapies for diabetes mellitus in pregnancy

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