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

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Status and phase: Completed; Phase 4

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

Treatments: Drug: medical nutrition therapy + metformin; Behavioral: Medical nutrition therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01675310

INPer (Mexico) (Registry Identifier)

Conacyt 151819

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

medical nutrition therapy + metformin

Experimental group

Description:

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

Treatment:

Drug: medical nutrition therapy + metformin

medical nutrition therapy

Active Comparator group

Description:

medical nutrition therapy without trans-gestational metformin

Treatment:

Behavioral: Medical nutrition therapy