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

Phase 2

Completed

• Conditions: Gestational Diabetes

• Registration Number: NCT00314717
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-13
• Study First Submitted QC: 2006-04-13
• Study First Posted: 2006-04-14
• Study Completion: 2007-04
• Status Verified: 2007-08
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fasting serum glucose	Baseline and 4 weeks
A1c	Baseline and 4 weeks
Self-blood-glucose-monitoring results	daily until delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada