Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial
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Gestational diabetes mellitus (GDM) is the most common metabolic disorder of pregnancy. The aim of the study is to compare the effect of different dosages of inositol stereoisomers supplementation on insulin resistance levels and several maternal-fetal outcomes in GDM women.
Participants were randomly allocated to receive daily: 400 mcg folic acid (control treatment), 4000 mg myo-inositol plus 400 mcg folic acid (MI treatment), 500 mg d-chiro-inositol plus 400 mcg folic acid (DCI treatment) or 1100/27.6 mg myo/d-chiro-inositol plus 400 mcg folic acid (MI plus DCI treatment). The homeostasis model assessment of insulin resistance (HOMA-IR) was measured at the diagnosis of GDM and after 8 weeks of treatment. Secondary outcomes, obstetric outcomes and any maternal or fetal complication at delivery were also collected.
Eighty GDM women were assigned to one of the four arms of study (20 per arm). A significant delta decrease in HOMA-IR index was found in subjects of MI group without insulin therapy compared to control group (p < 0.001). A lower variation in average weight gain (at delivery vs pre-pregnancy and OGTT period) was detected in MI group vs control group (p = 0.001 and p = 0.019, respectively). Moreover, women exposed to MI and MI plus DCI required a significantly lower necessity of an intensified insulin treatment. Women of the control group had newborns with higher birth weight compared with women treated with inositol (p = 0.032).
Our study provides interesting but preliminary results about the potential role of inositol stereoisomers supplementation in the treatment of GDM on insulin resistance levels and several maternal-fetal outcomes. Further studies are required to examine the optimal and effective dosages of different inositol supplements.
Clinical trial reg. no.
KeywordsGestational diabetes mellitus Myo-inositol d-Chiro-inositol Nutraceutics Insulin resistance Pregnancy outcome
Gestational diabetes mellitus
Homeostatic model assessment of insulin resistance
The authors wish to thank Lucrezia Gasparini for the contribution and all women who participated in this study.
The study was designed by EV, CC, BP, and GDV. CC and ML contributed to clinical evaluation and support to the recruitment of patients. FF contributed to data acquisition, analysis, and interpretation. The manuscript was drafted by FF, MF, and EV. MDN and IZ were the statisticians that performed and supervised the statistical analyses; they also helped in the drafting and editing of the manuscript. CC, FF, BP, GDV, MDN, and MF contributed to the reviewed of the manuscript. All authors were involved in critical revision and approved the final version of the manuscript before submission. EV and MDN are the guarantor of this work and, as such, had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical standard statement
The study was in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments.
Informed consent was obtained from the patients included in the study.
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