The Effect of a Low Glycemic Index Diet on Blood Sugar Co... | NCT00314717

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

NCT00314717

Sponsor

University of Toronto

Status

Completed

Last Update Posted

Jun 21, 2011Estimated

Enrollment

47Actual

Phase

Phase 2

Conditions

Gestational Diabetes

Interventions

Control diet
Low GI diet

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Apr 13, 2006

First Submission Date that Met QC Criteria

Apr 13, 2006

First Posted Date

Apr 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2011

Last Update Posted Date

Jun 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
maternal weight gain throughout pregnancy		weekly
number of individuals who receive insulin treatment while participating in the study		duration of pregnancy

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas MS Wolever, MD, PhD	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Michael's Hospital		Toronto	Ontario	M5B 1W8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21094553	Result	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.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Name	Type	Description	Arm Group Labels	Other Names
Control diet	Behavioral
Low GI diet	Behavioral