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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
medical nutrition therapy + metformin
Medical nutrition therapy
Sponsored by
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregestational Obesity (BMI > 27kg/m2) focused on measuring obesity, polycystic ovary syndrome, gestational diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • National Institute of Perinatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

medical nutrition therapy + metformin

medical nutrition therapy

Arm Description

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

medical nutrition therapy without trans-gestational metformin

Outcomes

Primary Outcome Measures

Gestational diabetes mellitus
oral glucose tolerance test

Secondary Outcome Measures

insulin resistance
measure of insulin resistance by HOMA-IR, sample of umbilical cord

Full Information

First Posted
August 27, 2012
Last Updated
March 23, 2015
Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT01675310
Brief Title
Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
Official Title
EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregestational Obesity (BMI > 27kg/m2), History of Polycystic Ovary Syndrome
Keywords
obesity, polycystic ovary syndrome, gestational diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
medical nutrition therapy + metformin
Arm Type
Experimental
Arm Description
medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
Arm Title
medical nutrition therapy
Arm Type
Active Comparator
Arm Description
medical nutrition therapy without trans-gestational metformin
Intervention Type
Drug
Intervention Name(s)
medical nutrition therapy + metformin
Intervention Type
Behavioral
Intervention Name(s)
Medical nutrition therapy
Intervention Description
medical nutrition therapy
Primary Outcome Measure Information:
Title
Gestational diabetes mellitus
Description
oral glucose tolerance test
Time Frame
27-28 weeks of gestation
Secondary Outcome Measure Information:
Title
insulin resistance
Description
measure of insulin resistance by HOMA-IR, sample of umbilical cord
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria: Body mass index > 27 kg/m2 Maternal age >25 History of infertility with polycystic ovary syndrome History of macrosomic newborn (Weight >4000g) History of diabetes mellitus in first or second degree. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Reyes-Muñoz, PhD
Organizational Affiliation
National Institute of Perinatology, Mexico City
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Perinatology
City
Mexico
ZIP/Postal Code
11000
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
35010938
Citation
Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.
Results Reference
derived
Links:
URL
http://journals.lww.com/greenjournal/Abstract/2014/05001/Medical_Nutrition_Therapy_Plus_Metformin_for.346.aspx
Description
Medical Nutrition Therapy Plus Metformin for Preventing Gestational Diabetes Among High-Risk Women.

Learn more about this trial

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

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