Medical Nutrition Therapy Program for Pregnant Women With Diabetes

NCT00860613 | Completed

• 1 other identifier: 212250-02091
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Type 2 Diabetes

Keywords

gestational diabetes; medical nutrition therapy program; glucose monitoring; metabolic control; nutritional status; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• metabolic control

  every two weeks

Secondary Outcomes (3)

• maternal nutritional status

  every two weeks

• fetal nutritional status

  at labor

• cost effectiveness

  3 years

Study Arms (3)

1

EXPERIMENTAL

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.

Other: medical nutrition therapy program

2

EXPERIMENTAL

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.

Other: medical nutrition therapy program

3

NO INTERVENTION

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.

Interventions

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Study Sites (1)

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Mexico City, Mexico City, 11700, Mexico

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Felipe Vadillo-Ortega, M.D, PhD

  Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

  STUDY CHAIR

• Otilia Perichart-Perera, M.S, RD

  Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

  PRINCIPAL INVESTIGATOR

• Margie Balas-Nakash, B.S

  Instituto Nacional de Perinatología Isidro Espionosa de los Reyes

  STUDY CHAIR

• Adalberto Parra-Covarrubias, M.D

  Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

  STUDY CHAIR

• Ameyalli Rodriguez-Cano, B.S

  Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: February 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2008
• Last Updated: March 12, 2009

Record last verified: 2009-03

Locations

ME (1)