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

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ClinicalTrials.gov Identifier: NCT00314717
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
University of Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Control diet Behavioral: Low GI diet Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
Study Start Date : April 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine





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

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


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00314717     History of Changes
Other Study ID Numbers: Protocol reference 16929
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: August 2007

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