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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01675310
First received: August 27, 2012
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:

Primary Outcome Measures:
  • Gestational diabetes mellitus [ Time Frame: 27-28 weeks of gestation ] [ Designated as safety issue: No ]
    oral glucose tolerance test


Secondary Outcome Measures:
  • insulin resistance [ Time Frame: At birth ] [ Designated as safety issue: No ]
    measure of insulin resistance by HOMA-IR, sample of umbilical cord


Enrollment: 90
Study Start Date: January 2012
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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)
Study First Received: August 27, 2012
Last Updated: March 23, 2015
Health Authority: Mexico: Institutional Review Board National Institute of Perinatology
Mexico: National Council of Science and Technology (CONACYT)

Keywords provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
obesity, polycystic ovary syndrome, gestational diabetes

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

ClinicalTrials.gov processed this record on March 25, 2015