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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014