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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00860613
Other study ID # 212250-02091
Secondary ID
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


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
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