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

June 20, 2011 updated by: University of Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting serum glucose
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
A1c
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Self-blood-glucose-monitoring results
Time Frame: daily until delivery
daily until delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Investigators

  • Principal Investigator: Thomas MS Wolever, MD, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (Estimate)

April 14, 2006

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol reference 16929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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