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Medical Nutrition Therapy Program for Pregnant Women With Diabetes

Primary Purpose

Gestational Diabetes, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
medical nutrition therapy program
Sponsored by
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, medical nutrition therapy program, glucose monitoring, metabolic control, nutritional status, cost effectiveness

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

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.

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.

women in this group received the current hospital treatment. They did not receive any intervention except for the self glucose monitoring that they did every two weeks. Weight gain and the results of the self glucose monitoring, were evaluated every two weeks.

Outcomes

Primary Outcome Measures

metabolic control

Secondary Outcome Measures

maternal nutritional status
fetal nutritional status
cost effectiveness

Full Information

First Posted
March 11, 2009
Last Updated
March 11, 2009
Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
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1. Study Identification

Unique Protocol Identification Number
NCT00860613
Brief Title
Medical Nutrition Therapy Program for Pregnant Women With Diabetes
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Type 2 Diabetes
Keywords
gestational diabetes, medical nutrition therapy program, glucose monitoring, metabolic control, nutritional status, cost effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
No Intervention
Arm Description
women in this group received the current hospital treatment. They did not receive any intervention except for the self glucose monitoring that they did every two weeks. Weight gain and the results of the self glucose monitoring, were evaluated every two weeks.
Intervention Type
Other
Intervention Name(s)
medical nutrition therapy program
Intervention Description
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 Outcome Measure Information:
Title
metabolic control
Time Frame
every two weeks
Secondary Outcome Measure Information:
Title
maternal nutritional status
Time Frame
every two weeks
Title
fetal nutritional status
Time Frame
at labor
Title
cost effectiveness
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Vadillo-Ortega, M.D, PhD
Organizational Affiliation
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Otilia Perichart-Perera, M.S, RD
Organizational Affiliation
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margie Balas-Nakash, B.S
Organizational Affiliation
Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adalberto Parra-Covarrubias, M.D
Organizational Affiliation
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ameyalli Rodriguez-Cano, B.S
Organizational Affiliation
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
City
Mexico
State/Province
Mexico City
ZIP/Postal Code
11700
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Medical Nutrition Therapy Program for Pregnant Women With Diabetes

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