The Effect of Myo-inositol Supplementation on the Prevention of Gestational Diabetes in Overweight Pregnant Women: a Randomized, Double-blind, Controlled Trial

Abstract Purpose: This study is striving to test the hypothesis that a low dosage of myo-inositol supplementation may decrease the likelihood of gestational diabetes in overweight, pregnant women. Methods: A randomized, double-blind, controlled trial was performed on 60 eligible overweight, pregnant women at 12-14 weeks of gestation at two Iranian obstetric clinics. The participants were divided into two groups based on blocked randomization. The myo-inositol group, receiving 2000 mg plus 200 μg folic acid daily and the control group, receiving 400 μg of folic acid daily from 14 - 24 gestational weeks. The occurrence of gestational diabetes was determined based on 75-g 2-hour oral glucose tolerance test (OGTT) at 24–28 gestational weeks, which was the primary outcome of the study. The secondary outcomes were: the evaluation of insulin therapy, insulin resistance, and lipid profile, gestational weight gain, as well as fetal and maternal outcomes. Results: The incidence of gestational diabetes in myo-inositol group was noticeably minimized compared with that of the control group (RR 0.29, 95% CI 0.09-0.94, p= 0.037). There were no differences between the two groups in terms of fasting blood sugar, fasting insulin, HOMA-IR, insulin therapy, and triglyceride. There was no report of severe adverse drug reactions, either.Conclusions: The absolute risk reduction and the ‘‘Number-Needed-to-Treat’’ for gestational diabetes were 26.8% (95% CI, 5.6–48) and 3.7 (95% CI, 2.1–18.0), respectively. Hence, it can be concluded that approximately one out of every four overweight pregnant women receiving myo-inositol benefitted from its daily intake.

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Effect of antenatal dietary myo-inositol supplementation on the incidence of gestational diabetes mellitus and fetal outcome: protocol for a double-blind randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-055314 ◽

2022 ◽

Vol 12 (1) ◽

pp. e055314

Author(s):

Ibrahim Ibrahim ◽

Hala Abdullahi ◽

Yassin Fagier ◽

Osman Ortashi ◽

Annalisa Terrangera ◽

...

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Controlled Trial ◽

Tolerance Test ◽

Dietary Advice ◽

Controlled Clinical Trial ◽

Oral Glucose ◽

Double Blind ◽

Registration Number

IntroductionGestational diabetes mellitus (GDM) affects 23.6% of Qatari women and is associated with maternal and perinatal morbidity and long-term risk of developing type 2 diabetes. A number of challenges exist with current interventions, including non-compliance with dietary advice, the reluctance of mothers to ingest metformin tablets or use insulin injections. These challenges highlight the importance of pursuing evidence-based prevention strategies. Myo-inositol is readily available as an US Food and Drug Administration-approved food supplement with emerging but limited evidence suggesting it may be beneficial in reducing the incidence of GDM. Further studies, such as this one, from different ethnic contexts and with differing risk factors, are urgently needed to assess myo-inositol effects on maternal and neonatal outcomes.Methods and analysisThis study is a prospective, randomised, double-blinded, placebo controlled clinical trial to either myo-inositol supplementation or placebo.We plan to enrol 640 pregnant women attending antenatal care at Sidra Medicine, Doha, Qatar, 320 in each arm. All participants will complete at least 12 weeks of supplementation prior to undertaking the Oral Glucose Tolerance Test at 24–28 weeks. The daily use of the trial supplementation will continue until the end of pregnancy. All outcome measures will be collected from the electronic medical records.Ethics and disseminationEthical approval for the study was obtained on 12 April 2021 from Sidra Medicine (IRB number 1538656). Results of the primary trial outcome and secondary endpoints will be submitted for publication in a peer-reviewed journal.Trial registration numberProspectively registered on 26 May 2021. Registration number ISRCTN16448440 (ISRCTN registry).

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Daily intake of heat-killed Lactobacillus plantarum L-137 improves inflammation and lipid metabolism in overweight healthy adults: a randomized-controlled trial

European Journal of Nutrition ◽

10.1007/s00394-019-02112-3 ◽

2019 ◽

Vol 59 (6) ◽

pp. 2641-2649 ◽

Cited By ~ 3

Author(s):

Yusuke Tanaka ◽

Yoshitaka Hirose ◽

Yoshihiro Yamamoto ◽

Yasunobu Yoshikai ◽

Shinji Murosaki

Keyword(s):

Lipid Metabolism ◽

Lactobacillus Plantarum ◽

Mononuclear Cells ◽

Controlled Trial ◽

Low Density Lipoprotein ◽

Daily Intake ◽

Density Lipoprotein ◽

Control Group ◽

Double Blind ◽

Peripheral Blood Mononuclear

Abstract Purpose The effects of heat-killed Lactobacillus plantarum L-137 (HK L-137) on inflammation and lipid metabolism were investigated in overweight volunteers. Methods One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4 years) were enrolled in this randomized, double-blind, placebo-controlled, parallel group study. Subjects were randomly assigned to daily administration of a tablet containing HK L-137 (10 mg) or a placebo tablet for 12 weeks. Blood samples were collected every 4 weeks to measure biomarkers of lipid metabolism and inflammatory mediators. Results The percent change of concanavalin A-induced proliferation of peripheral blood mononuclear cells was significantly larger in the HK L-137 group than in the control group, similar to previous studies. The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point. These effects of HK L-137 were stronger in the subjects with higher C-reactive protein levels. Conclusions These findings suggest that daily intake of HK L-137 can improve inflammation and lipid metabolism in subjects at risk of inflammation.

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Serum magnesium and copper levels in Bangladeshi women with gestational diabetes mellitus

IMC Journal of Medical Science ◽

10.3329/imcjms.v11i1.31935 ◽

2017 ◽

Vol 11 (1) ◽

pp. 25-28

Author(s):

Farzana Akonjee Mishu ◽

MA Muttalib

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Medical College Hospital ◽

Control Group ◽

Oral Glucose ◽

Third Trimester ◽

College Hospital ◽

Medical College

Background and objectives: Alteration of magnesium (Mg) and copper (Cu) concentrations in blood has been observed in normal pregnancy as well as in gestational diabetes mellitus (GDM). The present study was aimed to evaluate the serum Mg and Cu levels in Bangladeshi women with GDM in their second and third trimester of pregnancy.Methods: The study was conducted at Mymensingh Medical College Hospital from July 2013 to June 2014. Pregnant women, in their second and third trimester, attending the outpatient department of Obstetrics and Gynecology and the Department of Endocrinology of Mymensingh Medical College Hospital were enrolled by purposive sampling technique. GDM was diagnosed on the basis of oral glucose tolerance test (OGTT) as defined in WHO criteria 2013. Blood glucose was estimated by enzymatic GOD-PAP colorimetric method. The cut off value for fasting plasma glucose level was ?6.1 mmol/L or ?7.8 mmol/L 2 hours after glucose load. Serum Cu was estimated by 3, 5-DiBr-PAESA method and Mg by Xylidyl Blue-I Method as per manufacturers instruction.Results: A total of 172 pregnant women in their second and third trimester were enrolled. Out of 172 participants, 86 had GDM and 86 were normoglycemic (control). The mean age of GDM and control groups was 28.6±3.2 years and 27.3±3.1 years respectively. The BMI was 26.4±1.5 m/kg2 and 26.3±1.3 m/kg2. Serum Mg level was significantly low (p< 0.001) in 2nd and 3rd trimesters in GDM cases (1.39±0.26 mg/dl and 0.93±0.15 mg/dl) compared to control group (1.67±0.3 mg/dl and 1.67±0.31mg/dl). On the contrary, serum Cu levels in GDM cases were significantly (p<0.002) higher in both trimesters (224±333.8 ?g/dl and 243.91±6.89 ?g/dl) compared to those without GDM (220.1±7.6 ?g/dl and 234.9±4.6 ?g/dl). There was significant (p<0.001) increase of serum Cu levels in 3rd trimester compared to 2nd trimester in both GDM and non GDM cases.Conclusion: There was distinct alteration of serum Mg and Cu levels in GDM compared to normal pregnancy.IMC J Med Sci 2017; 11(1): 25-28

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Effects of metformin and insulin therapy regimens on postpartum oral glucose tolerance test results in pregnant women with gestational diabetes mellitus: a comparative study

Hormone Molecular Biology and Clinical Investigation ◽

10.1515/hmbci-2020-0018 ◽

2020 ◽

Vol 41 (4) ◽

Author(s):

Moghadaseh Jahanshahi ◽

Arash Rezaei Shahmirzadi ◽

Elham Kashani ◽

Reza Alipoor ◽

Shoreh Vosough

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Glucose Tolerance ◽

Insulin Therapy ◽

Pregnant Women ◽

Glucose Tolerance Test ◽

Tolerance Test ◽

Oral Glucose ◽

Oral Glucose Tolerance ◽

Maternal Weight

AbstractObjectivesThe main purpose of this study was to compare the effects of two regimens of metformin and insulin therapy on postpartum oral glucose tolerance test (OGTT) results in pregnant women with gestational diabetes mellitus (GDM).MethodsIn this single-blind randomized clinical trial (RCT), a total number of 60 pregnant women meeting the inclusion criteria were assigned to two groups with a randomized block design (RBD): insulin therapy (IT) group (30 patients) and metformin therapy (MT) group (30 patients). At baseline, the data were comprised of prenatal maternal age, gestational age, GDM diagnosis, and maternal weight/height. During the postpartum period, 5-cc blood samples were taken from the pregnant women concerned to analyze their fasting blood sugar (FBS) levels. Then, the patients were asked to come back four days and six weeks later after delivery to check the OGTT results. At six weeks postpartum, in addition to OGTT, the glycated hemoglobin (HbA1C) test was performed for all mothers. Finally, six weeks after delivery, these mothers were evaluated with regard to weight loss and body mass index (BMI).ResultsSix weeks postpartum, the maternal weight and BMI significantly decreased in the MT group compared with the IT one, while there was no significant difference between both groups at baseline. On the fourth day, the OGTT results in the MT group were significantly lower in comparison with those in the IT group (p=0.012). At sixth weeks postpartum, the OGTT results were comparably lower in the MT group than those reported for the IT one; however, such a difference was not statistically significant (p=0.087).ConclusionsAccording to the study results, metformin could be an effective and safe treatment for pregnant women suffering from GDM instead of insulin therapy.

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Modifying effects of maternal Hb concentration on infant birth weight in women receiving prenatal iron-containing supplements: a randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114515004870 ◽

2015 ◽

Vol 115 (4) ◽

pp. 644-649 ◽

Cited By ~ 6

Author(s):

Linlin Wang ◽

Zuguo Mei ◽

Hongtian Li ◽

Yali Zhang ◽

Jianmeng Liu ◽

...

Keyword(s):

Folic Acid ◽

Birth Weight ◽

Randomised Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Double Blind ◽

Randomised Controlled ◽

Hb Concentration ◽

Infant Birth ◽

Very High

AbstractConcerns have been raised about the benefits of Fe-containing supplements on infant birth weight among women with normal/high Hb levels at baseline. Thus far, no clinical trials have examined whether the effects of prenatal Fe-containing supplements on birth weight vary by maternal Hb levels. We compared the effects of Fe–folic acid (IFA) or multiple micronutrients (MMN) with folic acid (FA) supplements on birth weight among pregnant women with mild/no anaemia or high Hb levels. A double-blind randomised controlled trial was conducted in 2006–2009. In total, 18 775 pregnant women with mild/no anaemia (<100 g/l) were enrolled from five counties in north China. During the period from before 20 weeks of gestation to delivery, the women randomly received a daily supplement containing the following: (1) FA (400 μg); (2) IFA (FA, 400 μg; Fe, 30 mg); or (3) MMN (FA, Fe and thirteen additional vitamins and minerals). Birth weight was measured within the 1st hour of birth. Maternal Hb concentration was determined at enrolment. Among women with normal (≤132 g/l) or high (133–145 g/l) baseline Hb levels, IFA or MMN supplementation had no effect on birth weight. Among women with very high (>145 g/l) baseline Hb levels, IFA and MMN supplements increased birth weight by 91·44 (95 % CI 3·37, 179·51) g and 107·63 (95 % CI 21·98, 193·28) g (P<0·05), respectively, compared with the FA group. No differences were found between the IFA and the MMN group, regardless of maternal Hb concentration. In conclusion, the effects of Fe-containing supplements on birth weight depended on baseline Hb concentrations. The Fe-containing supplements improved birth weight in women with very high Hb levels before 20 weeks of gestation.

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The associations of incretin hormone concentration with gestational diabetes mellitus

Diabetes Mellitus ◽

10.14341/dm2004134-37 ◽

2016 ◽

Vol 19 (2) ◽

pp. 150-157 ◽

Cited By ~ 2

Author(s):

Tatiana V. Saprina ◽

Ekaterina S. Timokhina ◽

Olga K. Goncharevich ◽

Svetlana V. Budeeva ◽

Tatiana S. Prokhorenko ◽

...

Keyword(s):

Diabetes Mellitus ◽

Gestational Diabetes ◽

Gestational Diabetes Mellitus ◽

Pregnant Women ◽

Carbohydrate Metabolism ◽

Hormone Secretion ◽

Control Group ◽

Oral Glucose ◽

Incretin Hormone ◽

Metabolism Disorder

Background: Enteropancreatic hormonal system disorder is a possible reason for β-cell dysfunction and carbohydrate metabolism disorder among pregnant women. However, no information is available about the state of enteroinsulin hormones [glucagon, glucose-dependent insulinotropic peptide (GIP), glucagon-like peptide1 (GLP-1) and GLP-2] during pregnancy. The role of enteroinsulin hormones in the development of carbohydrate metabolism disorder during pregnancy is poorly understood. Aim: To quantify and compare incretin hormone secretion in groups of pregnant women with and without gestational diabetes mellitus (GDM). Materials and methods: The study included 80 patients, 50 of whom had GDM, and the control group consisted of 30 pregnant women without GDM. All patients underwent an oral glucose tolerance test; glycated haemoglobin (HbA1c) estimation; ferritin, transferrin, basal and postprandial glucagon estimation; GLP-1 and GLP-2 estimation. Results: Basal glucagon and GLP-1 levels were significantly higher (p 0. 05) in the group of women with GDM than in the control group. The most significant differences in GLP-1, basal and postprandial glucagon levels were observed during the first trimester of pregnancy. Conclusion: High GLP-1 levels in the group of women with GDM may reflect a state of ‘incretin resistance’, which is similar to hyperinsulinemia in the early stages of type 2 diabetes mellitus.

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Behaviors of Turkish pregnant women towards gestational diabetes screening

Pakistan Journal of Medical Sciences ◽

10.12669/pjms.37.5.4176 ◽

2021 ◽

Vol 37 (5) ◽

Author(s):

Hüseyin Aydoğmuş ◽

Serpil Aydoğmuş ◽

Halil Ibrahim Tıraş ◽

Zeynep Cankaya

Keyword(s):

Gestational Diabetes ◽

Pregnant Women ◽

Perinatal Death ◽

Gestational Hypertension ◽

Fetal Distress ◽

Control Group ◽

Oral Glucose ◽

Diabetes Screening ◽

Maternal Complications ◽

Gynecology And Obstetrics

Objectives: Although gestational diabetes is the most common metabolic disease in pregnancy some pregnant women still refuse to undergo oral glucose tolerance test (OGTT). The purpose of this study was to evaluate the behavior of pregnant women undergoing OGTT, and to compare perinatal results between women who undergo and refuse OGTT. Methods: This retrospective cohort study was performed by evaluating the data of Izmir Katip Celebi University Gynecology and Obstetrics outpatient clinic between 2012-2017. Data of 2079 pregnant were evaluated retrospectively. Among 373 women who refused OGTT were evaluated as the study group, while remaining 1706 women who underwent OGTT were considered as the control group. The groups were compared with regard to perinatal results. Results: Sixty-two point four percent of the group who refused OGTT had a C-section, while 56.3% of the control group had a C-section (p<0.05). Intrauterine growth retardation, fetal distress, amniotic fluid pathologies, macrosomia, gestational hypertension and perinatal death were slightly higher in pregnant women who did not undergo OGTT compared to the control group, however, the difference was not statistically significant. Conclusion: Maternal complications and poor pregnancy results were found slightly higher in pregnant women who refused OGTT. These results might be explained by assuring glycemic control in pregnant women who refused OGTT by a series of fasting and postprandial blood sugar measurements in our center. doi: https://doi.org/10.12669/pjms.37.5.4176 How to cite this:Aydogmus H, Aydogmus S, Tiras HI, Cankaya Z . Behaviors of Turkish pregnant women towards gestational diabetes screening. Pak J Med Sci. 2021;37(5):---------. doi: https://doi.org/10.12669/pjms.37.5.4176 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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The effect of zinc supplementation on pregnancy outcomes: a double-blind, randomised controlled trial, Egypt

British Journal Of Nutrition ◽

10.1017/s000711451500166x ◽

2015 ◽

Vol 114 (2) ◽

pp. 274-285 ◽

Cited By ~ 10

Author(s):

Samia A. Nossier ◽

Noha E. Naeim ◽

Nawal A. El-Sayed ◽

Azza A. Abu Zeid

Keyword(s):

Randomised Controlled Trial ◽

Pregnant Women ◽

Pregnancy Outcomes ◽

Controlled Trial ◽

Neonatal Morbidity ◽

Control Group ◽

Double Blind ◽

Serum Zn ◽

Randomised Controlled ◽

Low Serum

The present randomised controlled trial (RCT) was conducted to evaluate the effect of two regimens of Zn supplementation on pregnancy outcomes in Alexandria, Egypt. Healthy pregnant women aged 20–45 years and having low serum Zn level below the estimated median for the gestational age were eligible to participate in the trial. Of 1055 pregnant women assessed for the eligibility of low serum Zn level, 675 were eligible. These women were randomly assigned to one of the three groups: the Zn alone group (n 225) received a daily dose of 30 mg ZnSO4, the combined group (n 227) received 30 mg ZnSO4 plus multivitamins (B1, B6, D3, C and E) and the control group (n 223) received placebo (270 mg lactose). They were followed up from the time of recruitment till 1 week after delivery. Overall, there was no detectable difference in the mean birth weight between the three groups (mean 2929·12 (sd 330·28), 2922·22 (sd 324·05) and 2938·48 (sd 317·39) g for the placebo, Zn and Zn plus multivitamin groups, respectively, P= 0·88). Both the single and the combined Zn supplements were almost equally effective in reducing second- and third-stage complications (relative risk (RR) 0·43, 95 % CI 0·31, 0·60 for the Zn group and RR 0·54, 95 % CI 0·40, 0·73 for the combined group). Stillbirth and preterm delivery were significantly lower among the two supplemented groups than the placebo group (P= 0·001). Early neonatal morbidity was also significantly lower in the supplemented groups (RR 0·23, 95 % CI 0·15, 0·35 for the Zn group and RR 0·25, 95 % CI 0·16, 0·37 for the combined group). Collectively, Zn supplementation was effective in reducing pregnancy complications and early neonatal infection among the Zn-deficient women of the present trial.

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Effect of Carbohydrate-Restricted Dietary Pattern on Insulin Treatment Rate, Lipid Metabolism and Nutritional Status in Pregnant Women with Gestational Diabetes in Beijing, China

Nutrients ◽

10.3390/nu14020359 ◽

2022 ◽

Vol 14 (2) ◽

pp. 359

Author(s):

Mingxuan Cui ◽

Xuening Li ◽

Chen Yang ◽

Linlin Wang ◽

Lulu Lu ◽

...

Keyword(s):

Lipid Metabolism ◽

Gestational Diabetes ◽

Nutritional Status ◽

Insulin Therapy ◽

Pregnant Women ◽

Early Pregnancy ◽

Insulin Treatment ◽

Blood Glucose Control ◽

Control Group ◽

Significant Difference

Carbohydrates play an important role in blood glucose control in pregnant women with GDM. Carbohydrate-restricted dietary (CRD) pattern for gestational diabetes mellitus (GDM) has been widely used in clinics, but the change in insulin utilization rate beyond CRD intervention in GDM remains unclear. The aim of the present study was to explore the application of insulin in pregnancy with GDM, as well as the influence of CRD pattern on lipid metabolism and nutritional state. A retrospective study of 265 women with GDM who delivered in Peking University People’s Hospital from July 2018 to January 2020 was conducted using a questionnaire survey. Women were divided into a CRD group or a control group according to whether they had received CRD intervention during pregnancy. There was no statistically significant difference in the rate of insulin therapy between the two groups (p > 0.05), the initial gestational week of the CRD group combined with insulin treatment was significantly higher than that of the control group (p < 0.05), and the risk of insulin therapy was positively correlated with fasting plasma glucose (FPG) in early pregnancy (p < 0.05). The incidence of abnormal low-density lipoprotein cholesterol levels in the CRD group was significantly lower than that in the control group (p < 0.05). There were no significant differences in nutritional indexes between the two groups. The results indicate that CRD intervention may be effective in delaying the use of insulin and improving the blood lipids metabolism during GDM pregnancy, while nutritional status may not be significantly affected under CRD intervention, and a high FPG in early pregnancy with GDM may be a risk factor for combined insulin therapy with CRD intervention.

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Effect of individualized medical nutrition guidance on pregnancy outcomes in older pregnant women

Journal of International Medical Research ◽

10.1177/03000605211033193 ◽

2021 ◽

Vol 49 (8) ◽

pp. 030006052110331

Author(s):

Chun-Ling Li ◽

Ying-Hua Wang ◽

Jun-Li Wang ◽

Ping Zhang ◽

Yan Sun

Keyword(s):

Gestational Diabetes ◽

Pregnant Women ◽

Vaginal Delivery ◽

Pregnancy Outcomes ◽

Neonatal Intensive Care ◽

Controlled Trial ◽

Child Outcomes ◽

Control Group ◽

Study Group ◽

Medical Nutrition

Objective We aimed to explore the effect of individualized medical nutrition guidance on pregnancy outcomes among older pregnant women. Methods This was a prospective study using a randomized controlled trial design. We selected 820 older pregnant women and randomly divided them into a study group and control group (410 women each). The control group was given routine health education and nutrition guidance; the study group was provided individualized medical nutrition guidance. Gestational diabetes mellitus, hypertensive disorders of pregnancy, vaginal delivery rate, postpartum hemorrhage rate, gestational body weight, neonatal birth weight, and neonate transfer to the neonatal intensive care unit (NICU) were compared between the groups. Results The incidence of gestational diabetes in the study group was significantly lower and the rate of vaginal delivery was significantly higher than those in the control group. The incidence of macrosomia, rate of neonatal transfer to the NICU, and rate of neonatal hyperbilirubinemia were significantly lower in the study group than those in the control group. Conclusions Individualized nutritional intervention for older pregnant women can effectively reduce the incidence of complications during pregnancy and childbirth and improve maternal and child outcomes.

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