Gestational DiabetesPhase 2NCT00314717
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
A Phase 2 study testing Low GI diet in people with Gestational Diabetes, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Low GI diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with gestational hyperglycemia
- age between 18 and 45 inclusive
- willing and able to comply with protocol
Who cannot join
- <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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Gestational Diabetes
- Being tested
- Control diet, Low GI diet
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control dietBehavioural
Low GI dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting serum glucose
Measured: Baseline and 4 weeks
A1c
Measured: Baseline and 4 weeks
Self-blood-glucose-monitoring results
Measured: daily until delivery
Secondary outcomes (14)
maternal weight gain throughout pregnancy
Measured: weekly
number of individuals who receive insulin treatment while participating in the study
Measured: duration of pregnancy
latency to insulin requirement/ gestational age when prescribed insulin
Measured: duration of pregnancy
dosage and frequency of insulin
Measured: duration of pregnancy
ultrasound measurements (if available)
Measured: according to clinical practice
fasting lipids
Measured: Baseline and 4 weeks
fasting c-reactive protein
Measured: Baseline and 4 weeks
infant birth weight
Measured: at birth
infant blood glucose
Measured: at birth
infant plasma calcium
Measured: at birth
infant bilirubin at birth obtained via heel prick
Measured: at birth
birth complications
Measured: at birth
perceptions of educational materials
perceptions of diet treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startApr 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314717
- Sponsor's protocol ID
- Protocol reference 16929
- Status last verified
- Aug 2007
- First submitted
- 13 Apr 2006
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21094553
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia
- ClinicalTrials.gov ID
- NCT00314717
- Acronym / sponsor ID
- Protocol reference 16929
- Conditions
- Gestational Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 14 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women with gestational hyperglycemia
- age between 18 and 45 inclusive
- willing and able to comply with protocol
Key exclusion criteria (5 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control diet | Behavioural | – |
| Low GI diet | Behavioural | – |
Primary outcome
Fasting serum glucose
Time frame: Baseline and 4 weeks
A1c
Time frame: Baseline and 4 weeks
Self-blood-glucose-monitoring results
Time frame: daily until delivery
14 secondary outcomes
maternal weight gain throughout pregnancy
Time frame: weekly
number of individuals who receive insulin treatment while participating in the study
Time frame: duration of pregnancy
latency to insulin requirement/ gestational age when prescribed insulin
Time frame: duration of pregnancy
dosage and frequency of insulin
Time frame: duration of pregnancy
ultrasound measurements (if available)
Time frame: according to clinical practice
fasting lipids
Time frame: Baseline and 4 weeks
fasting c-reactive protein
Time frame: Baseline and 4 weeks
infant birth weight
Time frame: at birth
infant blood glucose
Time frame: at birth
infant plasma calcium
Time frame: at birth
infant bilirubin at birth obtained via heel prick
Time frame: at birth
birth complications
Time frame: at birth
perceptions of educational materials
perceptions of diet treatments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
- Results publication: PubMed 21094553Grant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas MS Wolever, MD, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low GI diet in people with Gestational Diabetes, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting serum glucose (time frame: Baseline and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00314717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2011.