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

History of Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675310
• Other study ID #: Conacyt 151819
• Secondary ID: INPer (Mexico)
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2012
• Last updated: March 23, 2015
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Institutional Review Board National Institute of PerinatologyMexico: National Council of Science and Technology (CONACYT)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• medical nutrition therapy + metformin

Behavioral:
• Medical nutrition therapy
medical nutrition therapy

Locations

Country	Name	City	State
Mexico	National Institute of Perinatology	Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes mellitus	oral glucose tolerance test	27-28 weeks of gestation	No
Secondary	insulin resistance	measure of insulin resistance by HOMA-IR, sample of umbilical cord	At birth	No

External Links

•   Medical Nutrition Therapy Plus Metformin for Preventing Gestational Diabetes Among High-Risk Women.