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

Primary Purpose

Diabetes, Gestational

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Nutrition education

About this trial

This is an interventional prevention trial for Diabetes, Gestational focused on measuring Randomized clinical trial, Gestational diabetes, Carbohydrates, Glycemic index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Mt Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

High fiber

Low GI

Arm 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.

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.

Outcomes

Primary Outcome Measures

Serum glucose concentration 1hr after glucose challenge test

Secondary Outcome Measures

GCT outcome

ie. normal, borderline, abnormal

GDM outcome

Presence or absence of gestational diabetes

Maternal weight

Mode of delivery

Normal or cesarean section

Presence of birth trauma

Weight of baby

Presence of macrosomia

presence of large for gestational age baby

Presence of small for gestational age baby

food frequency questionnaire

Acceptability of study foods

Full Information

NCT ID

NCT01105455

First Posted

April 9, 2010

Last Updated

March 11, 2013

Sponsor

University of Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01105455

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Gestational

Keywords

Randomized clinical trial, Gestational diabetes, Carbohydrates, Glycemic index

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High fiber

Arm Type

Placebo Comparator

Arm Description

Arm Title

Low GI

Arm Type

Active Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Nutrition education

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum glucose concentration 1hr after glucose challenge test

Time Frame

26 weeks gestation

Secondary Outcome Measure Information:

Title

GCT outcome

Description

ie. normal, borderline, abnormal

Time Frame

26 weeks gestation

Title

GDM outcome

Description

Presence or absence of gestational diabetes

Time Frame

26 weeks gestation

Title

Maternal weight

Time Frame

At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation

Title

Mode of delivery

Description

Normal or cesarean section

Time Frame

At time of birth of baby

Title

Presence of birth trauma

Time Frame

At time of birth of baby

Title

Weight of baby

Time Frame

At time of birth of baby

Title

Presence of macrosomia

Time Frame

At time of birth of baby

Title

presence of large for gestational age baby

Time Frame

At time of birth of baby

Title

Presence of small for gestational age baby

Time Frame

At time of birth of baby

Title

food frequency questionnaire

Time Frame

at 12 weeks and 26 weeks gestation

Title

Acceptability of study foods

Time Frame

26 weeks gestation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas MS Wolever, BM, BCh, PhD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mt Sinai Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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