Clinical trial NCT00860613: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Type 2 Diabetes
Keywords: gestational diabetes
medical nutrition therapy program
glucose monitoring
metabolic control
nutritional status
cost effectiveness
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
First posted: 2009-03-12
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: metabolic control
timeFrame: every two weeks
Secondary outcomes:
measure: maternal nutritional status
timeFrame: every two weeks
measure: fetal nutritional status
timeFrame: at labor
measure: cost effectiveness
timeFrame: 3 years
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
state: Mexico City
Study officials:
affiliation: Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
name: Felipe Vadillo-Ortega, M.D, PhD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
name: Otilia Perichart-Perera, M.S, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
name: Margie Balas-Nakash, B.S
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
name: Adalberto Parra-Covarrubias, M.D
role: STUDY_CHAIR
affiliation: Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
name: Ameyalli Rodriguez-Cano, B.S
role: STUDY_CHAIR
References: