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

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01105455

Collaborator

(none)

103

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes, Gestational	Other: Nutrition education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Other: Nutrition education Group nutrition classes supplemented by handouts and provision of key study foods.
Active Comparator: 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.	Other: Nutrition education Group nutrition classes supplemented by handouts and provision of key study foods.

Arm

Intervention/Treatment

Placebo Comparator: 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.

Other: Nutrition education

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

Active Comparator: 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.

Other: Nutrition education

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

Outcome Measures

Primary Outcome Measures

Serum glucose concentration 1hr after glucose challenge test [26 weeks gestation]

Secondary Outcome Measures

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]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mt Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator: Thomas MS Wolever, BM, BCh, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Wolever, Professor, University of Toronto

ClinicalTrials.gov Identifier:

NCT01105455

Other Study ID Numbers:

MSH REB 09-0263-E

First Posted:

Apr 16, 2010

Last Update Posted:

Mar 12, 2013

Last Verified:

Mar 1, 2013

Keywords provided by Thomas Wolever, Professor, University of Toronto

Randomized clinical trial

Gestational diabetes

Carbohydrates

Glycemic index

Additional relevant MeSH terms:

Diabetes, Gestational

Diabetes Mellitus

Study Results

No Results Posted as of Mar 12, 2013