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Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.

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ClinicalTrials.gov Identifier: NCT02708758
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Brief Summary:
There is a lack of international uniformity in the approach to the screening and diagnosis of gestational diabetes mellitus (GDM). The new diagnostic criteria by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) based on data from the study of Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have created controversy because of the lack of clinical evidence of treatment benefit for mild GDM and the treatment effects on perinatal outcomes. The purpose of the present study is to know the efficacy of treatment to reduce adverse pregnancy outcomes in Mexican women diagnosed with GDM by IADPSG criteria.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Medical Nutrition Therapy Not Applicable

Detailed Description:
Currently no evidence from randomized clinical trials on the efficacy of treatment of gestational diabetes mellitus (GDM), diagnosed by a single altered value during a 75g oral glucose tolerance test (75g OGTT), proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) to reduce adverse perinatal outcomes (APO). In our institution GDM diagnosis is established with two or more altered values during 75g OGTT, women with one altered value during OGTT are not considered GDM and therefore those women do not receive specific treatment for GDM. We conduct an open randomized clinical trial, two groups, Group 1 (women with treatment for GDM) and group 2 (women with routine care). The diagnosis of GDM will be perform with a single altered value during 75g OGTT: fasting ≥ 92mg / dL, 1-hour ≥ 180 mg / dL and 2-hours ≥ 153 mg / dL. Treatment consist of medical nutritional therapy (MNT), which includes restricted diet 45% carbohydrate, exercise and self-monitoring of glucose, if not reach therapeutic goals metformin and / or insulin will be added.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Treatment in Women With Gestational Diabetes Mellitus Diagnosed by One Altered Value by the International Association of Diabetes and Pregnancy Study Groups Criteria (IADPSG).
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment group
Medical nutrition therapy plus self monitoring capillary glucose levels and if necessary drug therapy (metformin or insulin) when goals are not met.
Behavioral: Medical Nutrition Therapy
individualized medical nutrition therapy from a qualified nutritionist which took into consideration a woman's pre-pregnancy weight, activity level, dietary intake and weight gain, instructions on how to self- monitoring capillary glucose levels two to four times daily until the levels had been in the recommended range (fasting glucose levels no more than 95 mg/dL and 1 hour postprandial less than 140 mg/dL). Drug therapy will begin with metformin or insulin when capillary glucose levels are not met the recommended levels after at least two weeks of treatment.

No Intervention: Routine care group
Prenatal routine care without medical nutrition therapy and without self monitoring capillary glucose levels and drug therapy specific for GDM.



Primary Outcome Measures :
  1. incidence of large for gestational age [ Time Frame: obstetrical resolution (birth) ]
    Sex specific birth weight for gestational age above the 90th percentile of Mexican fetal growth curves.


Secondary Outcome Measures :
  1. incidence of preeclampsia [ Time Frame: from 20 weeks of gestation to birth ]
    incidence of women at fina of gestation that have high blood pressure > 140/90 and proteinuria (more than 300 mg/dl) after 20 weeks of gestation.

  2. incidence of cesarean section [ Time Frame: from 26 weeks of gestation to birth ]
    Extraction of the fetus by means of abdominal hysterotomy.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy between 18-30 week´s gestation
  • 75-g oral glucose-tolerance test at 20-30 week´s gestation with only one altered value between: Fasting 92-99 mg/dL

    1. hour 180-211 mg/dL
    2. hour 153-177 mg/dL

      Exclusion Criteria:

  • Pregestational diabetes (first diagnosed in pregnancy) defined by altered values during 75-g oral glucose-tolerance test above:

Fasting >126 mg/dL 2 hour >200 mg/dL

-Two or more altered values during oral glucose tolerance test above: Fasting 92 mg/dL

  1. hour 180 mg/dL
  2. hour 153 mg/dL

    • Multiple pregnancy
    • Active chronic systemic disease as hyperthyroidism, hearth, hepatic or renal disease, immunological disease as lupus and chronic hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708758


Contacts
Contact: Enrique Reyes-Muñoz, MD. PhD +525555209900 ext 299 dr.enriquereyes@gmail.com

Locations
Mexico
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes Recruiting
Mexico City, Mexico, 11000
Contact: Nayeli Martínez-Cruz, MD    +525555209900 ext 299    nayemc_21@hotmail.com   
Contact: Enrique Reyes-Muñoz, MD, PhD.    +525555209900 ext 299    dr.enriquereyes@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Investigators
Principal Investigator: Enrique Reyes-Muñoz, MD, PhD. Department of Endocrinology (INPer)

Responsible Party: ENRIQUE REYES-Munoz MD, Researcher in Medical Sciences, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT02708758     History of Changes
Other Study ID Numbers: CONACYT 233634
212250-3402-10102-02-14 ( Registry Identifier: Instituto Nacional de Perinatología, (INPer) )
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications