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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Wolever, University of Toronto
ClinicalTrials.gov Identifier:
NCT01105455
First received: April 9, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Diabetes, Gestational
 Other: Nutrition education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Serum glucose concentration 1hr after glucose challenge test [ Time Frame: 26 weeks gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GCT outcome [ Time Frame: 26 weeks gestation ] [ Designated as safety issue: No ]
    ie. normal, borderline, abnormal

  • GDM outcome [ Time Frame: 26 weeks gestation ] [ Designated as safety issue: No ]
    Presence or absence of gestational diabetes

  • Maternal weight [ Time Frame: At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation ] [ Designated as safety issue: No ]
  • Mode of delivery [ Time Frame: At time of birth of baby ] [ Designated as safety issue: No ]
    Normal or cesarean section

  • Presence of birth trauma [ Time Frame: At time of birth of baby ] [ Designated as safety issue: No ]
  • Weight of baby [ Time Frame: At time of birth of baby ] [ Designated as safety issue: No ]
  • Presence of macrosomia [ Time Frame: At time of birth of baby ] [ Designated as safety issue: No ]
  • presence of large for gestational age baby [ Time Frame: At time of birth of baby ] [ Designated as safety issue: No ]
  • Presence of small for gestational age baby [ Time Frame: At time of birth of baby ] [ Designated as safety issue: No ]
  • food frequency questionnaire [ Time Frame: at 12 weeks and 26 weeks gestation ] [ Designated as safety issue: No ]
  • Acceptability of study foods [ Time Frame: 26 weeks gestation ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105455

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Thomas Wolever, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01105455     History of Changes
Other Study ID Numbers: MSH REB 09-0263-E
Study First Received: April 9, 2010
Last Updated: March 11, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Randomized clinical trial
Gestational diabetes
Carbohydrates
Glycemic index

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013