Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study
Metadatos
Mostrar el registro completo del ítemEditorial
BMJ
Fecha
2022-03-11Referencia bibliográfica
Amaefule CE... [et al.]. Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study. BMJ Open 2022;12:e050110. doi:[10.1136/bmjopen-2021-050110]
Patrocinador
Queen Mary University of London; Barts Charity MGU0373; NIHR Collaboration for Leadership in Applied Health Research at Barts Health NHS Foundation Trust (NIHR ARC North Thames); University of Granada by the Spanish Ministry of EducationResumen
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.