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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of Toronto

Current Primary Outcome: Serum glucose concentration 1hr after glucose challenge test [ Time Frame: 26 weeks gestation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • GCT outcome [ Time Frame: 26 weeks gestation ]
    ie. normal, borderline, abnormal
  • GDM outcome [ Time Frame: 26 weeks gestation ]
    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 ]
  • Mode of delivery [ Time Frame: At time of birth of baby ]
    Normal or cesarean section
  • Presence of birth trauma [ Time Frame: At time of birth of baby ]
  • Weight of baby [ Time Frame: At time of birth of baby ]
  • Presence of macrosomia [ Time Frame: At time of birth of baby ]
  • presence of large for gestational age baby [ Time Frame: At time of birth of baby ]
  • Presence of small for gestational age baby [ Time Frame: At time of birth of baby ]
  • food frequency questionnaire [ Time Frame: at 12 weeks and 26 weeks gestation ]
  • Acceptability of study foods [ Time Frame: 26 weeks gestation ]


Original Secondary Outcome:

  • GCT outcome [ Time Frame: 26 weeks gestation ]
    ie. normal, borderline, abnormal
  • GDM outcome [ Time Frame: 26 weeks gestation ]
    Presence or absence of gestational diabetes
  • Maternal weight [ Time Frame: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation ]
  • Mode of delivery [ Time Frame: At time of birth of baby ]
    Normal or cesarean section
  • Presence of birth trauma [ Time Frame: At time of birth of baby ]
  • Weight of baby [ Time Frame: At time of birth of baby ]
  • Presence of macrosomia [ Time Frame: At time of birth of baby ]
  • presence of large for gestational age baby [ Time Frame: At time of birth of baby ]
  • Presence of small for gestational age baby [ Time Frame: At time of birth of baby ]
  • food frequency questionnaire [ Time Frame: at 12 weeks and 26 weeks gestation ]
  • Acceptability of study foods [ Time Frame: 26 weeks gestation ]


Information By: University of Toronto

Dates:
Date Received: April 9, 2010
Date Started: March 2010
Date Completion:
Last Updated: March 11, 2013
Last Verified: March 2013