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

NCT01675310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Pregestational Obesity (BMI > 27kg/m2)
  • History of Polycystic Ovary Syndrome

Interventions

DRUG

medical nutrition therapy + metformin

BEHAVIORAL

Medical nutrition therapy

medical nutrition therapy

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

    lead OTHER_GOV

Principal Investigators

  • Enrique Reyes-Muñoz, PhD · National Institute of Perinatology, Mexico City

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675310 on ClinicalTrials.gov