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

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Control diet
Low GI diet
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • St. Michael's Hospital

Outcomes

Primary Outcome Measures

Fasting serum glucose
A1c
Self-blood-glucose-monitoring results

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2006
Last Updated
June 20, 2011
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT00314717
Brief Title
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
Official Title
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Control diet
Intervention Type
Behavioral
Intervention Name(s)
Low GI diet
Primary Outcome Measure Information:
Title
Fasting serum glucose
Time Frame
Baseline and 4 weeks
Title
A1c
Time Frame
Baseline and 4 weeks
Title
Self-blood-glucose-monitoring results
Time Frame
daily until delivery
Secondary Outcome Measure Information:
Title
maternal weight gain throughout pregnancy
Time Frame
weekly
Title
number of individuals who receive insulin treatment while participating in the study
Time Frame
duration of pregnancy
Title
latency to insulin requirement/ gestational age when prescribed insulin
Time Frame
duration of pregnancy
Title
dosage and frequency of insulin
Time Frame
duration of pregnancy
Title
ultrasound measurements (if available)
Time Frame
according to clinical practice
Title
fasting lipids
Time Frame
Baseline and 4 weeks
Title
fasting c-reactive protein
Time Frame
Baseline and 4 weeks
Title
infant birth weight
Time Frame
at birth
Title
infant blood glucose
Time Frame
at birth
Title
infant plasma calcium
Time Frame
at birth
Title
infant bilirubin at birth obtained via heel prick
Time Frame
at birth
Title
birth complications
Time Frame
at birth
Title
perceptions of educational materials
Title
perceptions of diet treatments

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas MS Wolever, MD, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21094553
Citation
Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20.
Results Reference
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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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