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The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia

This study has been completed.
Sponsor:
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00314717
First received: April 13, 2006
Last updated: June 20, 2011
Last verified: August 2007
History of Changes
  Purpose

The purpose of the study is to see if a low glycemic index diet will reduce blood sugar levels in pregnant women with high blood sugar levels.


Condition Intervention Phase
Gestational Diabetes
 Behavioral: Control diet
Behavioral: Low GI diet
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Fasting serum glucose [ Time Frame: Baseline and 4 weeks ]
  • A1c [ Time Frame: Baseline and 4 weeks ]
  • Self-blood-glucose-monitoring results [ Time Frame: daily until delivery ]

Secondary Outcome Measures:
  • maternal weight gain throughout pregnancy [ Time Frame: weekly ]
  • number of individuals who receive insulin treatment while participating in the study [ Time Frame: duration of pregnancy ]
  • latency to insulin requirement/ gestational age when prescribed insulin [ Time Frame: duration of pregnancy ]
  • dosage and frequency of insulin [ Time Frame: duration of pregnancy ]
  • ultrasound measurements (if available) [ Time Frame: according to clinical practice ]
  • fasting lipids [ Time Frame: Baseline and 4 weeks ]
  • fasting c-reactive protein [ Time Frame: Baseline and 4 weeks ]
  • infant birth weight [ Time Frame: at birth ]
  • infant blood glucose [ Time Frame: at birth ]
  • infant plasma calcium [ Time Frame: at birth ]
  • infant bilirubin at birth obtained via heel prick [ Time Frame: at birth ]
  • birth complications [ Time Frame: at birth ]
  • perceptions of educational materials
  • perceptions of diet treatments

Enrollment: 47
Study Start Date: April 2006
Study Completion Date: April 2007
Detailed Description:

Women with gestational hyperglycemia, including women with gestational diabetes and impaired glucose tolerance of pregnancy, consuming a low glycemic index (GI) diet will experience better blood glucose control thereby decreasing the risk associated complication(s).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with gestational hyperglycemia
  • age between 18 and 45 inclusive
  • willing and able to comply with protocol

Exclusion Criteria:

  • <18 or >45 years of age
  • other chronic or acute illness which affects carbohydrate metabolism
  • known multiple pregnancy
  • >34 weeks gestation
  • language barrier (no translator available)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314717

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
University of Toronto
Investigators
Principal Investigator: Thomas MS Wolever, MD, PhD University of Toronto
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00314717     History of Changes
Other Study ID Numbers: Protocol reference 16929
Study First Received: April 13, 2006
Last Updated: June 20, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 19, 2013