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OpenTrials
Completed

NCT Number: NCT00860613

Medical Nutrition Therapy Program for Pregnant Women With Diabetes

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Mexico City, 11700, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical nutrition therapy program

Other

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.

Primary outcomes

  1. metabolic control

    Time frame: every two weeks

Secondary outcomes

  1. maternal nutritional status

    Time frame: every two weeks

  2. fetal nutritional status

    Time frame: at labor

  3. cost effectiveness

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Other Gov

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Mar 12, 2009
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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