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

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ClinicalTrials.gov Identifier: NCT01675310
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

August 27, 2012
August 29, 2012
March 25, 2015
January 2012
December 2014   (Final data collection date for primary outcome measure)
Gestational diabetes mellitus [ Time Frame: 27-28 weeks of gestation ]
oral glucose tolerance test
Same as current
Complete list of historical versions of study NCT01675310 on ClinicalTrials.gov Archive Site
insulin resistance [ Time Frame: At birth ]
measure of insulin resistance by HOMA-IR, sample of umbilical cord
Same as current
Not Provided
Not Provided
 
Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pregestational Obesity (BMI > 27kg/m2)
  • History of Polycystic Ovary Syndrome
  • Drug: medical nutrition therapy + metformin
  • Behavioral: Medical nutrition therapy
    medical nutrition therapy
  • Experimental: medical nutrition therapy + metformin
    medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
    Intervention: Drug: medical nutrition therapy + metformin
  • Active Comparator: medical nutrition therapy
    medical nutrition therapy without trans-gestational metformin
    Intervention: Behavioral: Medical nutrition therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Same as current
March 2015
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01675310
Conacyt 151819
INPer (Mexico) ( Registry Identifier: 21225042101 )
Yes
Not Provided
Not Provided
ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
National Council of Science and Technology, Mexico
Principal Investigator: Enrique Reyes-Muñoz, PhD National Institute of Perinatology, Mexico City
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP