Gestational Diabetes, Type 2 Diabetes
Conditions
Keywords
gestational diabetes, medical nutrition therapy program, glucose monitoring, metabolic control, nutritional status, cost effectiveness
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.
Interventions
OTHERmedical 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.
Sponsors
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| metabolic control | every two weeks |
Secondary
| Measure | Time frame |
|---|---|
| maternal nutritional status | every two weeks |
| fetal nutritional status | at labor |
| cost effectiveness | 3 years |
Countries
Mexico
Outcome results
None listed