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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01675310
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Pregestational Obesity (BMI > 27kg/m2) History of Polycystic Ovary Syndrome Drug: medical nutrition therapy + metformin Behavioral: Medical nutrition therapy Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Study Start Date : January 2012
Primary Completion Date : December 2014
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: medical nutrition therapy + metformin
medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
Drug: medical nutrition therapy + metformin
Active Comparator: medical nutrition therapy
medical nutrition therapy without trans-gestational metformin
Behavioral: Medical nutrition therapy
medical nutrition therapy


Outcome Measures

Primary Outcome Measures :
  1. Gestational diabetes mellitus [ Time Frame: 27-28 weeks of gestation ]
    oral glucose tolerance test


Secondary Outcome Measures :
  1. insulin resistance [ Time Frame: At birth ]
    measure of insulin resistance by HOMA-IR, sample of umbilical cord


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675310


Locations
Mexico
National Institute of Perinatology
Mexico, Mexico, 11000
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Enrique Reyes-Muñoz, PhD National Institute of Perinatology, Mexico City
More Information

Additional Information:
Responsible Party: ENRIQUE REYES-Munoz MD, Clinical Reseach, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT01675310     History of Changes
Other Study ID Numbers: Conacyt 151819
INPer (Mexico) ( Registry Identifier: 21225042101 )
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
obesity, polycystic ovary syndrome, gestational diabetes

Additional relevant MeSH terms:
Genital Diseases, Female
Polycystic Ovary Syndrome
Diabetes, Gestational
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs