Medical Nutrition Therapy Program for Pregnant Women With Diabetes

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860613
• Other study ID #: 212250-02091
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: March 11, 2009
• Start date: February 2004
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: December 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Type 2 Diabetes

Intervention

Other:
• medical nutrition therapy program
the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	Mexico	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metabolic control		every two weeks	No
Secondary	maternal nutritional status		every two weeks	No
Secondary	fetal nutritional status		at labor	No
Secondary	cost effectiveness		3 years	No