Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial

Otilia Perichart-Perera, Jennifer Mier-Cabrera, Claudia Montserrat Flores-Robles, Nayeli Martínez-Cruz, Lidia Arce-Sánchez, Itzel Nallely Alvarado-Maldonado, Araceli Montoya-Estrada, José Romo-Yañez, Ameyalli Mariana Rodríguez-Cano, Guadalupe Estrada-Gutierrez, Salvador Espino Y Sosa, Mario Guzmán-Huerta, Rodrigo Ayala-Yañez, Enrique Reyes-Muñoz, Otilia Perichart-Perera, Jennifer Mier-Cabrera, Claudia Montserrat Flores-Robles, Nayeli Martínez-Cruz, Lidia Arce-Sánchez, Itzel Nallely Alvarado-Maldonado, Araceli Montoya-Estrada, José Romo-Yañez, Ameyalli Mariana Rodríguez-Cano, Guadalupe Estrada-Gutierrez, Salvador Espino Y Sosa, Mario Guzmán-Huerta, Rodrigo Ayala-Yañez, Enrique Reyes-Muñoz

Abstract

The aim of this study was to examine the efficacy of intensive medical nutrition therapy (MNT) plus metformin in preventing gestational diabetes mellitus (GDM) among high-risk Mexican women. An open-label randomized clinical trial was conducted. Inclusion criteria were pregnant women with three or more GDM risk factors: Latino ethnic group, maternal age >35 years, body mass index >25 kg/m2, insulin resistance, and a history of previous GDM, prediabetes, a macrosomic neonate, polycystic ovarian syndrome, or a first-degree relative with type 2 diabetes. Women before 15 weeks of gestation were assigned to group 1 (n = 45): intensive MNT-plus metformin (850 mg twice/day) or group 2 (n = 45): intensive MNT without metformin. Intensive MNT included individual dietary counseling, with ≤50% of total energy from high carbohydrates. The primary outcome was the GDM incidence according to the International Association of Diabetes Pregnancy Study Groups criteria. There were no significant differences in baseline characteristics and adverse perinatal outcomes between the groups. The GDM incidence was n = 11 (24.4%) in the MNT plus metformin group versus n = 7 (15.5%) in the MNT without metformin group: p = 0.42 (RR: 1.57 [95% CI: 0.67-3.68]). There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. Clinical trials registration: NCT01675310.

Keywords: diet; gestational diabetes; gestational weight gain; obesity; pregnancy.

Conflict of interest statement

O.P.-P., S.E.y.S. and E.R.-M., are speakers/consultants to the Nestlé Nutrition Institute. The rest of the authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram of participants included in the study. OGTT = oral glucose tolerance test MNT = medical nutrition therapy, MET = metformin, GDM = gestational diabetes mellitus.

References

    1. American Diabetes Association 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2021. Diabetes Care. 2021;44((Suppl. S1)):S15–S33. doi: 10.2337/dc21-S002.
    1. Hartling L., Dryden D.M., Guthrie A., Muise M., Vandermeer B., Donovan L. Benefits and Harms of Treating Gestational Diabetes Mellitus: A Systematic Review and Meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann. Intern. Med. 2013;159:123. doi: 10.7326/0003-4819-159-2-201307160-00661.
    1. Martis R., Crowther C.A., Shepherd E., Alsweiler J., Downie M.R., Brown J. Treatments for women with gestational diabetes mellitus: An overview of Cochrane systematic reviews. Cochrane Database Syst. Rev. 2018;2018:1–109. doi: 10.1002/14651858.CD012327.pub2.
    1. International Diabetes Federation . International Diabetes Federation. 9th ed. International Diabetes Federation; Brussels, Belgium: 2019. [(accessed on 5 January 2020)]. IDF Diabetes Atlas Ninth edition 2019. Available online: .
    1. Reyes-Muñoz E., Parra A., Castillo-Mora A., Ortega-González C. Effect of the Diagnostic Criteria of the International Association of Diabetes and Pregnancy Study Groups on the Prevalence of Gestational Diabetes Mellitus in Urban Mexican Women: A Cross-Sectional Study. Endocr. Pract. 2012;18:146–151. doi: 10.4158/EP11167.OR.
    1. American College of Obstetricians and Gynecologists Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin Number 190: Gestational Diabetes Mellitus Interim Update. Obstet. Gynecol. 2018;131:e49–e64. doi: 10.1097/AOG.0000000000002501.
    1. Egan A.M., Simmons D. Lessons learned from lifestyle prevention trials in gestational diabetes mellitus. Diabet. Med. 2019;36:142–150. doi: 10.1111/dme.13772.
    1. Mijatovic-Vukas J., Capling L., Cheng S., Stamatakis E., Louie J., Cheung N.W., Markovic T., Ross G., Senior A., Brand-Miller J.C., et al. Associations of Diet and Physical Activity with Risk for Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis. Nutrients. 2018;10:698. doi: 10.3390/nu10060698.
    1. Trine Moholdt T., Hayman M., Shorakae S., Brown W.J., Harrison C.L. The Role of Lifestyle Intervention in the Prevention and Treatment of Gestational Diabetes. Semin. Reprod. Med. 2020;38:398–406.
    1. Hyer S., Balani J., Shehata H. Metformin in Pregnancy: Mechanisms and Clinical Applications. Int. J. Mol. Sci. 2018;19:1954. doi: 10.3390/ijms19071954.
    1. Griffith R.J., Alsweiler J., Moore A.E., Brown S., Middleton P., Shepherd E., Crowther C.A. Interventions to prevent women from developing gestational diabetes mellitus: An overview of Cochrane Reviews. Cochrane Database Syst. Rev. 2020;6:CD012394.
    1. Reyes-Muñoz E., Martínez-Herrera E.M., Ortega-González C., Arce-Sánchez L., Ávila-Carrasco A., Zamora-Escudero R. HOMA-IR and QUICKI reference values during pregnancy in Mexican women. Ginecol. Obstet. Mex. 2017;85:306–313.
    1. Simmons D. Safety Considerations with Pharmacological Treatment of Gestational Diabetes Mellitus. Drug Saf. 2015;38:65–78. doi: 10.1007/s40264-014-0253-9.
    1. Martínez-Cruz N., Rapisarda A.G.C., Soriano-Ortega K.P., Arce-Sánchez L., Cianci A., Ortega-Gonzalez C., Torres-Herrera U., Espino-y-Sosa S., Estrada-Gutierrez G., Montoya-Estrada A., et al. Perinatal Outcomes in Mexican Women with Untreated Mild Gestational Diabetes Mellitus Diagnosed by the International Association of Diabetes and Pregnancy Study Groups Criteria. Diabetes Metab. Syndr. Obes. 2019;12:2667–2674. doi: 10.2147/DMSO.S229671.
    1. Mexican Secretary of Health Diabetes and Pregnancy, Technical Guideline. Mexico, Secretary of Health. 2017. [(accessed on 25 July 2020)]. Available online: .
    1. American Diabetes Association Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43((Suppl. S1)):S183–S192. doi: 10.2337/dc20-S014.
    1. Institute of Medicine . Weight Gain during Pregnancy: Reexamining the Guidelines. National Academies Press; Washington, DC, USA: 2009.
    1. Metzger B.E., Gabbe S.G., Persson B., Lowe L.P., Dyer A.R., Oats J.J.N., Buchanan T.A., International Association of Diabetes and Pregnancy Study Groups Consensus Panel International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010;33:676–682. doi: 10.2337/dc10-0719.
    1. American College of Obstetricians and Gynecologists, Task Force on Hypertension in Pregnancy Hypertension in Pregnancy. Obstet. Gynecol. 2013;122:1122–1131. doi: 10.1097/01.AOG.0000437382.03963.88.
    1. American College of Obstetricians and Gynecologists Practice Bulletin No. 159: Management of Preterm Labor. Obstet. Gynecol. 2016;127:e29–e38. doi: 10.1097/AOG.0000000000001265.
    1. Lim K.I., Butt K., Naud K., Smithies M. Amniotic Fluid: Technical Update on Physiology and Measurement. Obstet. Gynaecol. Can. 2017;39:52–58. doi: 10.1016/j.jogc.2016.09.012.
    1. Huerta S.F., Salgado H.M. Birth weight of male and female infants born in hospitals affiliated with the Instituto Mexicano del Seguro Social. Bol. Med. Hosp. Infant. Mex. 2012;69:30–39.
    1. Glueck C.J., Wang P., Kobayashi S., Phillips H., Sieve-Smith L. Metformin therapy throughout pregnancy reduces the development of gestational diabetes in women with polycystic ovary syndrome. Fertil. Steril. 2002;77:520–525. doi: 10.1016/S0015-0282(01)03202-2.
    1. Kenneth F., Schulz K.F., Altman D.G., Moher D., CONSORT Group CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Ann. Intern. Med. 2010;152:726–732.
    1. Morris S.F., Wylie-Rosett J. Medical Nutrition Therapy: A Key to Diabetes Management and Prevention. Clin. Diabetes. 2010;28:12–18. doi: 10.2337/diaclin.28.1.12.
    1. Martínez-Cruz N., Rapisarda A.M.C., Soriano-Ortega K.P., Arce-Sánchez L., Cianci A., Ortega-Gonzalez C., Torres-Herrera U., Espino-y-Sosa S., Estrada-Gutierrez G., Montoya-Estrada A. Diet and Nutritional Interventions with the Special Role of Myo-Inositol in Gestational Diabetes Mellitus Management. An Evidence-Based Critical Appraisal. Curr. Pharm. Des. 2019;25:2467–2473.
    1. Bennett C.J., Walker R.E., Blumfield M.L., Gwini S.-M., Ma J., Wang F., Wan Y., Dickinson H., Truby H. Interventions designed to reduce excessive gestational weight gain can reduce the incidence of gestational diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials. Diabetes Res. Clin. Pract. 2018;141:69–79. doi: 10.1016/j.diabres.2018.04.010.
    1. Shepherd E., Gomersall J.C., Tieu J., Han S., Crowther C.A., Middleton P. Combined diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst. Rev. 2017;11:CD010443. doi: 10.1002/14651858.CD010443.pub3.
    1. Reyes-Muñoz E., Guardo F.D., Ciebiera M., Kahramanoglu I., Sathyapalan T., Lin L., Shah M., Karaman E., Fan S., Zito G. Use of myo-inositol plus Bifidobacterium lactis and Lactobacillus rhamnosus for preventing gestational diabetes mellitus in Mexican women. Gac. Med. Mex. 2020;156((Suppl. S3)):S51–S57.
    1. Chatzakis C., Goulis D.G., Mareti E., Eleftheriades M., Zavlanos A., Dinas K., Sotiriadis A. Prevention of gestational diabetes mellitus in overweight or obese pregnant women: A network meta-analysis. Diabetes Res. Clin. Pract. 2019;158:107924. doi: 10.1016/j.diabres.2019.107924.
    1. Chiswick C., Reynolds R., Denison F., Drake A.J., Forbes S., Newby D.E., Walker B.R., Quenby S., Wray S., Weeks A., et al. Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): A randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2015;3:778–786. doi: 10.1016/S2213-8587(15)00219-3.
    1. Dodd J.M., Louise J., Deussen A.R., Grivell R., Dekker G., McPhee A.J., Hague W. Effect of metformin in addition to dietary and lifestyle advice for pregnant women who are overweight or obese: The GRoW randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019;7:15–24. doi: 10.1016/S2213-8587(18)30310-3.
    1. Knowler W.C., Barrett-Connor E., Fowler S.E., Hamman R.F., Lachin J.M., Walker E.A., Nathan D.M., Diabetes Prevention Program Research Group Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N. Engl. J. Med. 2002;346:393–403.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir