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

NCT ID: NCT00314717

Last Updated: 2011-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-04-30

Brief Summary

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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

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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).

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Control diet

Intervention Type BEHAVIORAL

Low GI diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 21094553 (View on PubMed)

Other Identifiers

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Protocol reference 16929

Identifier Type: -

Identifier Source: org_study_id

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