Maternal Lifestyle and Neonatal Hypoglycemia

Summary

tPA has a pivotal role in placentation, mediationg activation of growth factors, such as vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of extracellular matrix and basement membrane (directly or through activation of matrix metalloproteinases) and formation of hemidesmosomes.

A high-carbohydrate intake combined with lack of physical activity provides a strong stimulus for maternal insulin production. In this scenario, either β-cells are dysfunctional and diabetes supervenes, or excessive amounts of insulin are produced, providing pathological stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor, PAI-1 excess may affect placentation, increasing the risk of first trimester losses, preterm deliveries and intrauterine growth restriction.

Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of insulin.

Conditions

• Hyperinsulinemia
• Miscarriages
• Pregnancy
• Sedentary Lifestyle
• Hypoglycemia

Interventions

BEHAVIORAL

Daily brisk walking plus a carbohydrate-restricted diet

Daily brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7 days a week. Patients will be recommended to avoid high-glycemic index meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Recommendations will be emphasised at every appointment. Antidepressants will not be discontinued in both groups, but patients on paroxetine and sertraline, will be switched to fluoxetine.

Sponsors & Collaborators

• Rio de Janeiro State Research Supporting Foundation (FAPERJ)

  collaborator OTHER_GOV

• Hospital dos Servidores do Estado do Rio de Janeiro

  lead OTHER_GOV

Principal Investigators

• Maria A Sayeg-Porto, MD, PhD · Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro

• Paulo R Benchimol-Barbosa, MD, DSc · Universidade Gama Filho; COPPE/UFRJ

• Silvia Hoirisch-Clapauch, MD · Hospital dos Servidores do Estado, RJ

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2013-04-30

Completion

2015-10-31

Countries

• Brazil

Study Locations