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

Not Applicable

Completed

• Conditions: Diabetes, Gestational
• Interventions: Other: Nutrition education

• Registration Number: NCT01105455
• Lead Sponsor: University of Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High fiber	Nutrition education	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.
Low GI	Nutrition education	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.

Primary Outcome Measures

Name	Time	Method
Serum glucose concentration 1hr after glucose challenge test	26 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Mode of delivery	At time of birth of baby	Normal or cesarean section
GCT outcome	26 weeks gestation	ie. normal, borderline, abnormal
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
Presence of birth trauma	At time of birth of baby
Weight of baby	At time of birth of baby
Presence of macrosomia	At time of birth of baby
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

Trial Locations

Locations (1)

Mt Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada