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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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medical nutrition therapy + metformin

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

Group Type EXPERIMENTAL

medical nutrition therapy + metformin

Intervention Type DRUG

medical nutrition therapy

medical nutrition therapy without trans-gestational metformin

Group Type ACTIVE_COMPARATOR

Medical nutrition therapy

Intervention Type BEHAVIORAL

medical nutrition therapy

Interventions

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medical nutrition therapy + metformin

Intervention Type DRUG

Medical nutrition therapy

medical nutrition therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No