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

NCT01105455 | Completed

• 1 other identifier: MSH REB 09-0263-E
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Keywords

Randomized clinical trial; Gestational diabetes; Carbohydrates; Glycemic index

Outcome Measures

Primary Outcomes (1)

• Serum glucose concentration 1hr after glucose challenge test

  26 weeks gestation

Secondary Outcomes (11)

• GCT outcome

  26 weeks gestation

• GDM outcome

  26 weeks gestation

• 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

• Presence of birth trauma

  At time of birth of baby

Study Arms (2)

High fiber

PLACEBO COMPARATOR

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

Low GI

ACTIVE COMPARATOR

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

Interventions

Nutrition education OTHER

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

High fiber; Low GI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Mt Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Thomas MS Wolever, BM, BCh, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 16, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

CA (1)