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

This study is currently recruiting participants.
Verified August 2012 by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
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: August 28, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675310

Contacts
Contact: Enrique Reyes-Muñoz, MD 52 (55) 55209900 ext 299 dr.enriquereyes@gmail.com
Contact: Carlos Ortega-Gonzalez, MD 52 (55) 55209900 ext 307 ortegagonzalez@hotmail.com

Locations
Mexico
National Institute of Perinatology Recruiting
Mexico, Mexico, 11000
Contact: Enrique Reyes-Muñoz, MD     52 (55)55209900 ext 299     dr.enriquereyes@gmail.com    
Contact: Carlos Orega-Gonzalez, MD     52 (55) 55209900 ext 307     ortegagonzalez@hotmail.com    
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
National Council of Science and Technology, Mexico
  More 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: August 28, 2012
Health Authority: Mexico: Institutional Review Board National Institute of Perinatology
Mexico: National Council of Science and Technology (CONACYT)
Mexico: COFEPRIS Federal Comission for Prevention of Sanitary Risk

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

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

ClinicalTrials.gov processed this record on May 23, 2013