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

Phase 4

Completed

• Conditions: History of Polycystic Ovary Syndrome; Pregestational Obesity (BMI > 27kg/m2)
• Interventions: Drug: medical nutrition therapy + metformin; Behavioral: Medical nutrition therapy

• Registration Number: NCT01675310
• Lead Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Primary Completion: 2014-12
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medical nutrition therapy + metformin	medical nutrition therapy + metformin	medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
medical nutrition therapy	Medical nutrition therapy	medical nutrition therapy without trans-gestational metformin

Primary Outcome Measures

Name	Time	Method
Gestational diabetes mellitus	27-28 weeks of gestation	oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
insulin resistance	At birth	measure of insulin resistance by HOMA-IR, sample of umbilical cord

Trial Locations

Locations (1)

National Institute of Perinatology; 🇲🇽 Mexico, Mexico