NCT02708758

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

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).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2016-03-15
• Last updated: 2021-12-28

Locations

1 site across 1 country: Mexico