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

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105455
• Other study ID #: MSH REB 09-0263-E
• Status: Completed
• Phase: N/A
• First received: April 9, 2010
• Last updated: March 11, 2013
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational

Intervention

Other:
• Nutrition education
Group nutrition classes supplemented by handouts and provision of key study foods.

Locations

Country	Name	City	State
Canada	Mt Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum glucose concentration 1hr after glucose challenge test		26 weeks gestation	No
Secondary	GCT outcome	ie. normal, borderline, abnormal	26 weeks gestation	No
Secondary	GDM outcome	Presence or absence of gestational diabetes	26 weeks gestation	No
Secondary	Maternal weight		At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation	No
Secondary	Mode of delivery	Normal or cesarean section	At time of birth of baby	No
Secondary	Presence of birth trauma		At time of birth of baby	No
Secondary	Weight of baby		At time of birth of baby	No
Secondary	Presence of macrosomia		At time of birth of baby	No
Secondary	presence of large for gestational age baby		At time of birth of baby	No
Secondary	Presence of small for gestational age baby		At time of birth of baby	No
Secondary	food frequency questionnaire		at 12 weeks and 26 weeks gestation	No
Secondary	Acceptability of study foods		26 weeks gestation	No