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

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Status: Unknown

Conditions: Gestational Diabetes

Treatments: Behavioral: Medical Nutrition Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02708758

CONACYT 233634

212250-3402-10102-02-14 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

Medical nutrition therapy plus self monitoring capillary glucose levels and if necessary drug therapy (metformin or insulin) when goals are not met.

Treatment:

Behavioral: Medical Nutrition Therapy

Routine care group

No Intervention group

Description:

Prenatal routine care without medical nutrition therapy and without self monitoring capillary glucose levels and drug therapy specific for GDM.