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

NCT ID: NCT01105455

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-12-31

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.

Conditions

Diabetes, Gestational

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High fiber

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.

Group Type: PLACEBO_COMPARATOR

Nutrition education

Intervention Type: OTHER

Group nutrition classes supplemented by handouts and provision of key study foods.

Low GI

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.

Group Type: ACTIVE_COMPARATOR

Nutrition education

Intervention Type: OTHER

Group nutrition classes supplemented by handouts and provision of key study foods.

Interventions

Nutrition education

Group nutrition classes supplemented by handouts and provision of key study foods.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Thomas Wolever

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas MS Wolever, BM, BCh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Mt Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

MSH REB 09-0263-E

Identifier Type: -

Identifier Source: org_study_id