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Clinical Trials/NCT00314717
NCT00314717CompletedPhase 2

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

University of Toronto2 sites in 1 country47 target enrollmentStarted: April 2006Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
47
Locations
2
Primary Endpoint
Fasting serum glucose
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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 Outcomes

  • infant birth weight(at birth)
  • infant blood glucose(at birth)
  • infant plasma calcium(at birth)
  • 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 bilirubin at birth obtained via heel prick(at birth)
  • birth complications(at birth)
  • perceptions of educational materials
  • perceptions of diet treatments

Investigators

Sponsor Class
Other

Study Sites (2)

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