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OpenTrials
Completed

NCT Number: NCT01675310

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

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.

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Key information

Conditions

Pregestational Obesity (BMI > 27kg/m2) Adnexal Diseases Body Weight Cysts Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders History of Polycystic Ovary Syndrome Metabolic Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Perinatology

México, State of Mexico, 11000, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
  • Body mass index > 27 kg/m2
  • Maternal age >25
  • History of infertility with polycystic ovary syndrome
  • History of macrosomic newborn (Weight >4000g)
  • History of diabetes mellitus in first or second degree.
  • History of gestational diabetes in previous pregnancy

Exclusion criteria

  • Any form of pregestational diabetes
  • Fasting glucose > 126 mg/dL at first prenatal visit.
  • seric creatinine > 1.5 mg/dL
  • Hyperthyroidism
  • Heart disease
  • Hepatic disease
  • Renal diseases
  • Epilepsy
  • Lupus
  • Chronic hypertension.

Treatment and study plan

medical nutrition therapy + metformin

Drug

Medical Nutrition Therapy

Behavioral

medical nutrition therapy

Primary outcomes

  1. Gestational diabetes mellitus

    Time frame: 27-28 weeks of gestation

    oral glucose tolerance test

Secondary outcomes

  1. insulin resistance

    Time frame: At birth

    measure of insulin resistance by HOMA-IR, sample of umbilical cord

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Other Gov

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 29, 2012
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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