Article Text

Original research
Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study
  1. Chiamaka Esther Amaefule1,
  2. Zoe Drymoussi1,
  3. Francisco Jose Gonzalez Carreras1,
  4. Maria del Carmen Pardo Llorente2,
  5. Doris Lanz1,
  6. Julie Dodds1,
  7. Lorna Sweeney3,
  8. Elena Pizzo4,
  9. Amy Thomas1,5,
  10. James Heighway1,
  11. Jahnavi Daru1,
  12. Soha Sobhy1,5,
  13. Lucilla Poston6,
  14. Asma Khalil7,8,
  15. Jenny Myers9,
  16. Angela Harden3,
  17. Graham Hitman10,
  18. Khalid Saeed Khan11,
  19. Javier Zamora12,13,
  20. Teresa Pérez1,14,
  21. Mohammed S B Huda15,
  22. Shakila Thangaratinam13,16
  1. 1BARC (Barts Research Centre for Women’s Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK
  2. 2Department of Statistics and Operational Research, Complutense University of Madrid, Madrid, Spain
  3. 3Institute for Health and Human Development, University of East London, London, UK
  4. 4NIHR ARC (Applied Health Collaborations) for North Thames London, Department of Applied Health Research, University College London, London, UK
  5. 5Women’s and Children’s Health, Barts Health NHS Trust, The Royal London Hospital, London, UK
  6. 6Department of Women and Children’s Health, Faculty of Life Sciences and Medicine, King's College London, London, UK
  7. 7Department of Obstetrics and Gynaecology, St George's Hospital, London, UK
  8. 8Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK
  9. 9Maternal and Fetal Health Research Centre, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
  10. 10Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, Barts and The London School of Medicine and Dentistry, London, UK
  11. 11Department of Preventive Medicine and Public Health, Universidad de Granada, Granada, Spain
  12. 12Clinical Biostatistics Unit and CIBER Epidemiology and Public Health, IRYCIS, Madrid, Spain
  13. 13WHO Collaborating Centre for Global Women’s Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
  14. 14Department of Statistics and Data Science, Complutense University of Madrid, Madrid, Spain
  15. 15Barts Health NHS Trust, The Royal London Hospital, Department of Diabetes and Metabolism, London, UK
  16. 16Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK
  1. Correspondence to Professor Shakila Thangaratinam; s.thangaratinam.1{at}bham.ac.uk

Abstract

Objectives To determine the feasibility and acceptability of conducting a randomised trial on the effects of myo-inositol in preventing gestational diabetes in high-risk pregnant women.

Design A multicentre, double-blind, placebo-controlled, pilot randomised trial with nested qualitative evaluation.

Setting Five inner city UK National Health Service hospitals

Participants Multiethnic pregnant women at 12+0 and 15+6 weeks’ gestation with risk factors for gestational diabetes.

Interventions 2 g of myo-inositol or placebo, both included 200 µg folic acid, twice daily until delivery.

Primary outcome measures Rates of recruitment, randomisation, adherence and follow-up.

Secondary outcome measures Glycaemic indices (including homoeostatic model assessment-insulin resistance HOMA-IR), gestational diabetes (diagnosed using oral glucose tolerance test at 28 weeks and by delivery), maternal, perinatal outcomes, acceptability of intervention and costs.

Results Of the 1326 women screened, 58% (773/1326) were potentially eligible, and 27% (205/773) were recruited. We randomised 97% (198/205) of all recruited women (99 each in intervention and placebo arms) and ascertained outcomes in 90% of women (178/198) by delivery. The mean adherence was 52% (SD 44) at 28 weeks’ and 34% (SD 41) at 36 weeks’ gestation. HOMA-IR and serum insulin levels were lower in the myo-inositol vs placebo arm (mean difference −0.6, 95% CI −1.2 to 0.0 and −2.69, 95% CI −5.26 to −0.18, respectively). The study procedures were acceptable to women and healthcare professionals. Women who perceived themselves at high risk of gestational diabetes were more likely to participate and adhere to the intervention. The powder form of myo-inositol and placebo, along with nausea in pregnancy were key barriers to adherence.

Conclusions A future trial on myo-inositol versus placebo to prevent gestational diabetes is feasible. The intervention will need to be delivered in a non-powder form to improve adherence. There is a signal for efficacy in reducing insulin resistance in pregnancy with myo-inositol.

Trial registration number ISRCTN48872100.

  • diabetes in pregnancy
  • health economics
  • maternal medicine
  • qualitative research
  • public health

Data availability statement

Data are available on reasonable request. Release of data will be subject to a data use agreement between the contractor and the third party requesting the data. The data use agreement must detail the agreed use and appropriate management of the research data to be shared and include a requirement for recognition of the contribution of the researchers who generated the data and the original funder.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Data availability statement

Data are available on reasonable request. Release of data will be subject to a data use agreement between the contractor and the third party requesting the data. The data use agreement must detail the agreed use and appropriate management of the research data to be shared and include a requirement for recognition of the contribution of the researchers who generated the data and the original funder.

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Footnotes

  • Twitter @lorna_sweeney, @profasmakhalil, @Profkkhan

  • Contributors CEA: wrote the first and final version of the manuscript, collected and analysed the qualitative data. ZD, DL, JDo and JH: coordinated the study, contributed to the methodology and the final version of the manuscript. LS and AH: supervised the qualitative evaluation and has contributed to the final version of the manuscript. EP: developed and conducted the economic evaluation. EP also contributed to the final version of the manuscript. AT, JDa, SS, LP, AK, JM, GH, KSK and MSBH: provided clinical input and contributed to the final version of the manuscript. JZ, MdCPL and TP: developed and lead the statistical evaluation and contributed to the final version of the manuscript. FJGC: conducted the statistical analysis and contributed to the final version of the manuscript. ST: designed and developed the trial, reviewed the manuscript, has contributed to the final version of the manuscript, and is the guarantor of the manuscript.

  • Funding The EMmY trial is sponsored by Queen Mary University of London and funded by Barts Charity, grant number MGU0373. EP and AH are also supported by the NIHR Collaboration for Leadership in Applied Health Research at Barts Health NHS Foundation Trust (NIHR ARC North Thames). KSK is distinguished investigator funded by the Beatriz Galindo (senior modality) grant to the University of Granada by the Spanish Ministry of Education.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.