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

EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675310

Enrollment

Registered

2012-08-29

Start date

2012-01-31

Completion date

2015-03-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

obesity, polycystic ovary syndrome, gestational diabetes

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.

Interventions

DRUGmedical nutrition therapy + metformin

BEHAVIORALMedical nutrition therapy

medical nutrition therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026