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

NCT ID: NCT02708758

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2021-12-31

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: ACTIVE_COMPARATOR

Medical Nutrition Therapy

Intervention Type: BEHAVIORAL

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.

Routine care group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

OTHER_GOV

Sponsor Role: lead

Responsible Party

ENRIQUE REYES-Munoz MD

Researcher in Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrique Reyes-Muñoz, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology (INPer)

Locations

Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Enrique Reyes-Muñoz, MD. PhD

Role: CONTACT

Phone: +525555209900

Email: dr.enriquereyes@gmail.com

Facility Contacts

Nayeli Martínez-Cruz, MD

Role: primary

Enrique Reyes-Muñoz, MD, PhD.

Role: backup

Other Identifiers

212250-3402-10102-02-14

Identifier Type: REGISTRY

Identifier Source: secondary_id

CONACYT 233634

Identifier Type: -

Identifier Source: org_study_id