Clinical trial NCT02708758: Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
First posted: 2016-03-15
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: incidence of large for gestational age
timeFrame: obstetrical resolution (birth)
Secondary outcomes:
measure: incidence of preeclampsia
timeFrame: from 20 weeks of gestation to birth
measure: incidence of cesarean section
timeFrame: from 26 weeks of gestation to birth
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Study officials:
affiliation: Department of Endocrinology (INPer)
name: Enrique Reyes-Muñoz, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: