NCT01675310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.9 years

First QC Date

August 27, 2012

Last Update Submit

March 23, 2015

Conditions

Pregestational Obesity (BMI > 27kg/m2)History of Polycystic Ovary Syndrome

Keywords

obesity, polycystic ovary syndrome, gestational diabetes

Outcome Measures

Primary Outcomes (1)

  • Gestational diabetes mellitus

    oral glucose tolerance test

    27-28 weeks of gestation

Secondary Outcomes (1)

  • insulin resistance

    At birth

Study Arms (2)

medical nutrition therapy + metformin

EXPERIMENTAL

medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)

Drug: medical nutrition therapy + metformin

medical nutrition therapy

ACTIVE COMPARATOR

medical nutrition therapy without trans-gestational metformin

Behavioral: Medical nutrition therapy

Interventions

medical nutrition therapy + metforminDRUG
medical nutrition therapy + metformin
Medical nutrition therapyBEHAVIORAL

medical nutrition therapy

medical nutrition therapy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mexican women with pregnancy \< 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
  • Body mass index \> 27 kg/m2
  • Maternal age \>25
  • History of infertility with polycystic ovary syndrome
  • History of macrosomic newborn (Weight \>4000g)
  • History of diabetes mellitus in first or second degree.
  • History of gestational diabetes in previous pregnancy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Perinatology

México, State of Mexico, 11000, Mexico

Location

Related Publications (1)

  • Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.

    PMID: 35010938DERIVED

Related Links

MeSH Terms

Conditions

ObesityPolycystic Ovary SyndromeDiabetes, Gestational

Interventions

Nutrition TherapyMetformin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPregnancy ComplicationsDiabetes MellitusGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Enrique Reyes-Muñoz, PhD

    National Institute of Perinatology, Mexico City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Reseach

Study Record Dates

First Submitted

August 27, 2012

First Posted

August 29, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

ME(1)