Myoinositol plus α-lactalbumin supplementation, insulin resistance and birth outcomes in women with gestational diabetes mellitus: a randomized, controlled study

Rosario D'Anna; Francesco Corrado; Saverio Loddo; Giuseppe Gullo; Loretta Giunta; Antonino Di Benedetto

doi:10.1038/s41598-021-88329-x

Myoinositol plus α-lactalbumin supplementation, insulin resistance and birth outcomes in women with gestational diabetes mellitus: a randomized, controlled study

D'Anna R, Corrado F, Loddo S, Gullo G, Giunta L, Di Benedetto A

Published April 23, 2021 Scientific reports

DOI 10.1038/s41598-021-88329-x PMID 33893377 PMC PMC8065046

RRM Academy Synopsis

Myo-inositol with α-lactalbumin may lower insulin resistance in GDM

A randomized trial of 120 women with gestational diabetes mellitus (GDM) found insulin resistance was lower after two months with myo-inositol plus α-lactalbumin than with folic acid alone. About 7 out of 100 treated women needed insulin. About 20 out of 100 controls did. No treated woman delivered preterm.

Key Findings

The trial enrolled 120 women with gestational diabetes mellitus. Researchers assigned 60 to the supplement plus folic acid and 60 to folic acid alone for 2 months. All but one finished.
Insulin resistance (HOMA-IR) after 2 months was significantly lower in the treated group than in the control group (p = 0.0002).
Insulin treatment was needed by 4 of 60 treated women (6.7%) and 12 of 59 controls (20.3%) (p = 0.03).
No treated woman delivered preterm, while 9 of 59 controls (15.2%) did (p = 0.007).
Large-for-gestational-age births occurred in 4 treated women (6.7%) and 7 controls (11.9%), and hypertensive disorders in 2 (3.3%) and 7 (11.9%). Neither difference was significant.

Interpretation

The study was a single-center, open-label randomized trial. Women were diagnosed at 24 to 28 weeks of pregnancy and treated for 2 months, with birth outcomes recorded at delivery. Treated women began with significantly higher insulin resistance than controls, and the difference reversed by the end of treatment. Among the pregnancy complications compared, preterm birth was the only one with a significant difference. Fetal abdominal circumference centiles were also lower in the treated group. The authors note the small number of women enrolled as a limitation.

RRM Context

The authors cite earlier work with PCOS. Myo-inositol gave regular cycles and pregnancies there. Some women responded poorly, probably from impaired absorption. The team added α-lactalbumin to improve bioavailability. PCOS now also goes by PMOS (Polyendocrine Metabolic Ovarian Syndrome). Restorative reproductive medicine looks for metabolic causes of PCOS, such as insulin resistance. This trial asks a similar question in gestational diabetes.

Our editorial summary of this paper, not the article's abstract.

Abstract

To verify whether myo-inositol plus α-lactalbumin may reduce insulin resistance and excessive fetal growth in women with gestational diabetes mellitus. In a 12-month period, 120 women with a diagnosis of gestational diabetes mellitus were consecutively enrolled with an allocation of 1:1 in each group and randomly treated with myo-inositol plus α-lactalbumin plus folic acid (treated group) or folic acid (control group) for 2 months. Primary outcome was the variation of insulin resistance through the study evaluated by HOMA-IR. Secondary outcome was the evaluation, through the study, of fetal growth by ultrasound measurements of abdominal circumference centiles and estimated fat thickness. Some clinical outcomes were also considered. After 2 months, in the treated group, a significant reduction in insulin resistance (HOMA values 3.1 ± 1.4 vs 6.1 ± 3.4, p = 0.0002) and fetal growth was shown (Abdominal circumference centiles 54.9 ± 23.5 vs 67.5 ± 22.6, P = 0.006). Among clinical outcomes, a significant decrease in the rate of women who needed insulin (6.7% vs 20.3%, p = 0.03) and of pre-term birth (0 vs 15.2%, p = 0.007) was evidenced. A combination of myo-inositol and α-lactalbumin may reduce insulin resistance and excessive fetal growth.

Trial Registration

ClinicalTrials.gov, http://www.clinicaltrials.gov , NCT03763669, first posted date 04/12/2018; last posted date December 06/12/2018.

Rosario D'Anna, Francesco Corrado, Saverio Loddo, Giuseppe Gullo, Loretta Giunta, Antonino Di Benedetto

R D'Anna, F Corrado, S Loddo, G Gullo, L Giunta, A Benedetto

PMID 33893377 33893377 DOI 10.1038/s41598-021-88329-x 10.1038/s41598-021-88329-x D'Anna et al. 2021, D'Anna 2021

Myoinositol plus α-lactalbumin supplementation, insulin resistance and birth outcomes in women with gestational diabetes mellitus: a randomized, controlled study

Myo-inositol with α-lactalbumin may lower insulin resistance in GDM

Key Findings

Interpretation

RRM Context

Abstract

By this author

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