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


Phase 4
18 Years
50 Years
Open (Enrolling)
Female
Pregestational Obesity (BMI > 27kg/m2), History of Polycystic Ovary Syndrome

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Trial Information

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


Inclusion Criteria:



- Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance
75g-2h test and 3 or more criteria:

1. Body mass index > 27 kg/m2

2. Maternal age >25

3. History of infertility with polycystic ovary syndrome

4. History of macrosomic newborn (Weight >4000g)

5. History of diabetes mellitus in first or second degree.

6. 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Gestational diabetes mellitus

Outcome Description:

oral glucose tolerance test

Outcome Time Frame:

27-28 weeks of gestation

Safety Issue:

No

Authority:

Mexico: Institutional Review Board National Institute of Perinatology

Study ID:

Conacyt 151819

NCT ID:

NCT01675310

Start Date:

October 2011

Completion Date:

January 2014

Related Keywords:

  • Pregestational Obesity (BMI > 27kg/m2)
  • History of Polycystic Ovary Syndrome
  • obesity, polycystic ovary syndrome, gestational diabetes
  • Obesity
  • Polycystic Ovary Syndrome
  • Diabetes, Gestational

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