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

March 23, 2015 updated by: ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico, Mexico, 11000
        • National Institute of Perinatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational diabetes mellitus
Time Frame: 27-28 weeks of gestation
oral glucose tolerance test
27-28 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin resistance
Time Frame: At birth
measure of insulin resistance by HOMA-IR, sample of umbilical cord
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Collaborators

National Council of Science and Technology, Mexico

Investigators

  • Principal Investigator: Enrique Reyes-Muñoz, PhD, National Institute of Perinatology, Mexico City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Conacyt 151819
  • INPer (Mexico) (Registry Identifier: 21225042101)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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