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Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial

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Abstract

Aims

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.

Methods

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.

Results

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).

Conclusions

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.

NCT02097069, ClinicalTrial.gov.

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Abbreviations

GDM:

Gestational diabetes mellitus

MI:

Myo-inositol

DCI:

d-Chiro-inositol

HOMA-IR:

Homeostatic model assessment of insulin resistance

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Acknowledgements

The authors wish to thank Lucrezia Gasparini for the contribution and all women who participated in this study.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.

Author information

Authors and Affiliations

  1. Department of Medicine and Aging, School of Medicine and Health Sciences, “G. d’Annunzio” University Chieti-Pescara, Via dei Vestini, 66100, Chieti, Italy

    Federica Fraticelli, Claudio Celentano, Marco Liberati, Marica Franzago & Ester Vitacolonna

  2. Department of Medicine and Science of Ageing, School of Hygiene and Preventive Medicine, “G. D’Annunzio” University Chieti-Pescara, Chieti, Italy

    Isaia AL Zecca

  3. Diabetes Unit, Cantù Hospital, Abbiategrasso, Italy

    Giacoma Di Vieste

  4. Diabetes Unit, Niguarda Cà Granda Hospital, Milan, Italy

    Basilio Pintaudi

  5. Laboratory of Biostatistics, Department of Medical, Oral and Biotechnological Sciences, “G. D’Annunzio” University Chieti-Pescara, Chieti, Italy

    Marta Di Nicola

Authors
  1. Federica Fraticelli
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  2. Claudio Celentano
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  3. Isaia AL Zecca
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  4. Giacoma Di Vieste
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  5. Basilio Pintaudi
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  6. Marco Liberati
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  7. Marica Franzago
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  8. Marta Di Nicola
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  9. Ester Vitacolonna
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Contributions

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.

Corresponding author

Correspondence to Ester Vitacolonna.

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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

Informed consent was obtained from the patients included in the study. 

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Managed By Massimo Federici.

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Fraticelli, F., Celentano, C., Zecca, I.A. et al. Effect of inositol stereoisomers at different dosages in gestational diabetes: an open-label, parallel, randomized controlled trial. Acta Diabetol 55, 805–812 (2018). https://doi.org/10.1007/s00592-018-1157-4

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