Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women

Phase 4 Completed 90 enrolled Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes National Council of Science and Technology, Mexico · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world. There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population. Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus. Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.

Timeline

Start: 2012-01
Primary completion: 2014-12
Completion: 2015-03

Outcome

Missed primary endpoint

paper group: p = 0.42 (RR: 1.57 [95% CI: 0.67-3.68]). PMID 35010938 ↗

paper There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. PMID 35010938 ↗

Publications

Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	850 mg	—