Medical Nutrition Therapy Program for Pregnant Women With Diabetes

Not Applicable

Completed

• Conditions: Gestational Diabetes; Type 2 Diabetes
• Interventions: Other: medical nutrition therapy program

• Registration Number: NCT00860613
• Lead Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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 (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) 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 complications)will be measured at labor.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2007-06
• Study Completion: 2008-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Last Update Submitted: 2009-03-11
• Study First Posted: 2009-03-12
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

Inclusion Criteria

• pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes.
• less than 30 weeks of gestation
• women who plan to attend their pregnancy at the institution (INPerIER)

Exclusion Criteria

• women with type 1 pregestational diabetes or gestational diabetes type A1.
• women with multiple pregnancies
• women with renal or hepatic disease
• women who could not follow the dietary recommendations within the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	medical nutrition therapy program	women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. They received a specific diet using carbohydrate counting (40-45% of carbohydrates)and a moderate energy restriction. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring.
2	medical nutrition therapy program	Women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. The diet they received was based on carbohydrate counting (40-45% of carbohydrates), but recommended only low-moderate glycemic index foods. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring.

Primary Outcome Measures

Name	Time	Method
metabolic control	every two weeks

Secondary Outcome Measures

Name	Time	Method
maternal nutritional status	every two weeks
fetal nutritional status	at labor
cost effectiveness	3 years

Trial Locations

Locations (1)

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes; 🇲🇽 Mexico, Mexico City, Mexico