# NIH grant: Metabolic Assessment of Metformin in Pregnancy (MoM-P) (1R01HD120371-01) — retained record

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[original source ↗](https://reporter.nih.gov/project-details/1R01HD120371-01)

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NIH grant 1R01HD120371-01: Metabolic Assessment of Metformin in Pregnancy (MoM-P)
Institute: {'code': 'HD', 'abbreviation': 'NICHD', 'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development', 'admin_org_id': '12500030', 'admin_funding_url': ''}. PI: Patrick  Catalano. Award: $672715.
Start: 2026-06-18T00:00:00.
PROJECT SUMMARY
The objective of the “Metabolic Assessment of Metformin in Pregnancy “(MoM-P) proposal is to assess the
physiological effect of metformin on maternal and neonatal metabolism during pregnancy in individuals
developing gestational diabetes (GDM). Metformin is increasingly being used for medical treatment of GDM not
adequately treated with nutrition and physical activity. There is inconsistency among various organizations
(Society for Maternal Fetal Medicine, American College of Obstetrics and Gynecology and the American
Diabetes Association) as to metformin’s role in the medical management of GDM. We will examine the metabolic
action of metformin in GDM pregnancies and effect on mothers and their offspring. We plan to recruit 50
participants from Massachusetts General Hospital (MGH) for Specific Aims 1, 2 and 3 and 100 participants from
Ohio State University college of Medicine (OSUCOM) for Specific Aims 2 and 3. Participants for the study will
have been diagnosed with GDM requiring medical management of GDM as part of the DECIDE multicenter
randomized controlled trial. The primary site for DECIDE is OSUCOM, with Dr. Mark Landon as the PI. The
MoM-P study will recruit participants from the DECIDE trial at MGH and OSUCOM. The MoM-P study aims are:
Aim 1: To establish metformin’s effects on endogenous (primarily hepatic) glucose production (EGP)
and insulin sensitivity in late pregnancy. We hypothesize that metformin does not lower EGP in pregnancy
and hence the need of additional insulin in the medical management of GDM. We will perform infusion of a stable
isotope of glucose (6,6 2H2 glucose) to estimate EGP and a HOMA-IR prior to initiation of medical management
and again at 37 weeks gestation.
Aim 2: Metformin increases GDF15 levels in human GDM pregnancy and is associated with lower nutrient
intake, gestational weight gain (GWG) and increased resting energy expenditure (REE). We hypothesize
that metformin increases GDF15 concentrations which lead to GI upset, lower caloric intake/GWG and increases
REE. In DECIDE participants randomized to metformin vs. insulin, we will measure GDF15 and examine the
relationship to ASA-nutrition records, REE with indirect calorimetry and maternal body composition using air
displacement plethysmography (ADP) prior to initiation of medication and again at 37 weeks.
Aim 3: To compare fetal growth and body composition in neonates exposed and unexposed to metformin
in utero. We hypothesize that metformin treatment of GDM decreases fetal weight: 1) directly based on
metformin’s effect on neonatal metabolism (fetal AMPK and mTOR pathways) and 2) indirectly by lowering
maternal nutritional intake, fat free mass (FFM) and increasing maternal REE, resulting in decreased neonatal
FFM and increased fat mass in childhood. In DECIDE participants, we will measure neonatal body composition
with 72 hours of delivery using pediatric ADP and a planned follow-up of children at 2 years in the DECIDE
protocol with estimates of male and female children’s body composition.
```



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