The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes

University of Toronto

Status: Completed

Conditions: Diabetes, Gestational

Treatments: Other: Nutrition education

Study type: Interventional

Funder types: Other

Identifiers

NCT01105455

MSH REB 09-0263-E

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups, including a placebo group

High fiber

Placebo Comparator group

Description:

High fiber carbohydrate foods with a high / medium glycemic index. Whole wheat bread and/or brown rice are provided to subjects if they wish. Subjects are provided with a list of other recommended carbohydrate foods.

Treatment:

Other: Nutrition education

Low GI

Active Comparator group

Description:

Carbohydrate foods with a low glycemic index. Low GI rice and whole grain bread provided to subjects if they wish. Subjects are provided with a list of recommended foods.

Treatment:

Other: Nutrition education