NCT00314717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

June 21, 2011

Status Verified

August 1, 2007

First QC Date

April 13, 2006

Last Update Submit

June 20, 2011

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (3)

  • Fasting serum glucose

    Baseline and 4 weeks

  • A1c

    Baseline and 4 weeks

  • Self-blood-glucose-monitoring results

    daily until delivery

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Interventions

Control dietBEHAVIORAL
Low GI dietBEHAVIORAL

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with gestational hyperglycemia
  • age between 18 and 45 inclusive
  • willing and able to comply with protocol

You may not qualify if:

  • \<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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21094553RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas MS Wolever, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 14, 2006

Study Start

April 1, 2006

Study Completion

April 1, 2007

Last Updated

June 21, 2011

Record last verified: 2007-08

Locations

CA(1)