Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Medical Nutrition Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes
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
- hour 180-211 mg/dL
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
- hour 180 mg/dL
hour 153 mg/dL
- Multiple pregnancy
- Active chronic systemic disease as hyperthyroidism, hearth, hepatic or renal disease, immunological disease as lupus and chronic hypertension
Sites / Locations
- Instituto Nacional de Perinatología Isidro Espinosa de los ReyesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment group
Routine care group
Arm Description
Medical nutrition therapy plus self monitoring capillary glucose levels and if necessary drug therapy (metformin or insulin) when goals are not met.
Prenatal routine care without medical nutrition therapy and without self monitoring capillary glucose levels and drug therapy specific for GDM.
Outcomes
Primary Outcome Measures
incidence of large for gestational age
Sex specific birth weight for gestational age above the 90th percentile of Mexican fetal growth curves.
Secondary Outcome Measures
incidence of preeclampsia
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.
incidence of cesarean section
Extraction of the fetus by means of abdominal hysterotomy.
Full Information
NCT ID
NCT02708758
First Posted
February 22, 2016
Last Updated
December 24, 2021
Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
1. Study Identification
Unique Protocol Identification Number
NCT02708758
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Medical nutrition therapy plus self monitoring capillary glucose levels and if necessary drug therapy (metformin or insulin) when goals are not met.
Arm Title
Routine care group
Arm Type
No Intervention
Arm Description
Prenatal routine care without medical nutrition therapy and without self monitoring capillary glucose levels and drug therapy specific for GDM.
Intervention Type
Behavioral
Intervention Name(s)
Medical Nutrition Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of large for gestational age
Description
Sex specific birth weight for gestational age above the 90th percentile of Mexican fetal growth curves.
Time Frame
obstetrical resolution (birth)
Secondary Outcome Measure Information:
Title
incidence of preeclampsia
Description
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.
Time Frame
from 20 weeks of gestation to birth
Title
incidence of cesarean section
Description
Extraction of the fetus by means of abdominal hysterotomy.
Time Frame
from 26 weeks of gestation to birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
hour 180-211 mg/dL
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
hour 180 mg/dL
hour 153 mg/dL
Multiple pregnancy
Active chronic systemic disease as hyperthyroidism, hearth, hepatic or renal disease, immunological disease as lupus and chronic hypertension
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Reyes-Muñoz, MD. PhD
Phone
+525555209900
Ext
299
Email
dr.enriquereyes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Reyes-Muñoz, MD, PhD.
Organizational Affiliation
Department of Endocrinology (INPer)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
City
Mexico City
ZIP/Postal Code
11000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayeli Martínez-Cruz, MD
Phone
+525555209900
Ext
299
Email
nayemc_21@hotmail.com
First Name & Middle Initial & Last Name & Degree
Enrique Reyes-Muñoz, MD, PhD.
Phone
+525555209900
Ext
299
Email
dr.enriquereyes@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.
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