Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00860613
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2009-03-11
Brief Title:
Medical Nutrition Therapy Program for Pregnant Women With Diabetes
Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Organization:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study Overview
Official Title:
Medical Nutrition Therapy Program for Pregnant Women With Diabetes Evaluation of Two Different Dietary Strategies on Metabolic Control Maternal and Fetal Nutritional Status and Cost Effectiveness
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
No dietary strategies have been designed and proved for Mexican pregnant women with diabetes This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control maternal and fetal nutritional status and cost effectiveness Participants were randomly assigned to one of three medical nutrition therapy MNT groups the MNT 1 group n38 received usual medical treatment counseling from a nutritionist and diabetes educator using carbohydrate counting 40-45 of carbohydrateswith an intensive educational component MNT2 group n50 had the same treatment but included only low-moderate glycemic index foods and NO-MNT group n45 received the current hospital treatment All women will receive a glucose meter so they do self glucose monitoring pre and postprandial 2 times a weeks 6 times a day Weight gain dietary consumption and glucose concentrations will be evaluated every two weeks Fetal outcomes weight length and presence of complicationswill be measured at labor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None