Diabetes, Gestational
Conditions
Keywords
Randomized clinical trial, Gestational diabetes, Carbohydrates, Glycemic index
Brief summary
Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.
Interventions
OTHERNutrition education
Group nutrition classes supplemented by handouts and provision of key study foods.
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Attending Mt. Sinai Maternal Fetal Medicine Unit * Any ONE of: body mass index \>=25 kg/m\^2 * OR age \>=35 years * OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)
Exclusion criteria
* Have pre-existing diabetes (type 1 or type 2) before becoming pregnant * Acute or chronic illness which may affect carbohydrate metabolism * Language/literacy barriers which cannot be overcome via available resources * \>16 weeks gestation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum glucose concentration 1hr after glucose challenge test | 26 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GDM outcome | 26 weeks gestation | Presence or absence of gestational diabetes |
| Maternal weight | At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation | — |
| Mode of delivery | At time of birth of baby | Normal or cesarean section |
| Presence of birth trauma | At time of birth of baby | — |
| Weight of baby | At time of birth of baby | — |
| GCT outcome | 26 weeks gestation | ie. normal, borderline, abnormal |
| presence of large for gestational age baby | At time of birth of baby | — |
| Presence of small for gestational age baby | At time of birth of baby | — |
| food frequency questionnaire | at 12 weeks and 26 weeks gestation | — |
| Acceptability of study foods | 26 weeks gestation | — |
| Presence of macrosomia | At time of birth of baby | — |
Countries
Canada
Outcome results
None listed