Diabetes, GestationalNCT01105455
The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes
A study testing Nutrition education in people with Diabetes, Gestational, run by University of Toronto at 1 site in Canada.
Trial summary
Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Nutrition education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Attending Mt. Sinai Maternal Fetal Medicine Unit
- Any ONE of: body mass index >=25 kg/m^2
- OR age >=35 years
- OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)
Who cannot join
- Have pre-existing diabetes (type 1 or type 2) before becoming pregnant
- Acute or chronic illness which may affect carbohydrate metabolism
- Language/literacy barriers which cannot be overcome via available resources
- >16 weeks gestation
Trial locations and contacts
1 site in 1 country.
About this study
Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.
- Conditions
- Diabetes, Gestational
- Being tested
- Nutrition education
- Keywords
- Randomized clinical trial, Gestational diabetes, Carbohydrates, Glycemic index
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationOther
Group nutrition classes supplemented by handouts and provision of key study foods.
| Study group | Role | What they receive |
|---|---|---|
| High fiber | Placebo comparator | High fiber carbohydrate foods with a high / medium glycemic index. Whole wheat bread and/or brown rice are provided to subjects if they wish. Subjects are provided with a list of other recommended carbohydrate foods. Receives: Other: Nutrition education |
| Low GI | Active comparator | Carbohydrate foods with a low glycemic index. Low GI rice and whole grain bread provided to subjects if they wish. Subjects are provided with a list of recommended foods. Receives: Other: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum glucose concentration 1hr after glucose challenge test
Measured: 26 weeks gestation
Secondary outcomes (11)
GCT outcome
ie. normal, borderline, abnormal
Measured: 26 weeks gestation
GDM outcome
Presence or absence of gestational diabetes
Measured: 26 weeks gestation
Maternal weight
Measured: At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation
Mode of delivery
Normal or cesarean section
Measured: At time of birth of baby
Presence of birth trauma
Measured: At time of birth of baby
Weight of baby
Measured: At time of birth of baby
Presence of macrosomia
Measured: At time of birth of baby
presence of large for gestational age baby
Measured: At time of birth of baby
Presence of small for gestational age baby
Measured: At time of birth of baby
food frequency questionnaire
Measured: at 12 weeks and 26 weeks gestation
Acceptability of study foods
Measured: 26 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Wolever, University of Toronto
- Investigators
- Thomas MS Wolever, BM, BCh, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105455
- Sponsor's protocol ID
- MSH REB 09-0263-E
- Status last verified
- Mar 2013
- First submitted
- 9 Apr 2010
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. 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 Pregnant Women at Risk for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01105455
- Acronym / sponsor ID
- MSH REB 09-0263-E
- Conditions
- Diabetes, Gestational
- Keywords
- Randomized clinical trial, Gestational diabetes, Carbohydrates, Glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Apr 2010 (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.
Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fiber | Placebo comparator | Other: Nutrition educationHigh fiber carbohydrate foods with a high / medium glycemic index. Whole wheat bread and/or brown rice are provided to subjects if they wish. Subjects are provided with a list of other recommended carbohydrate foods. |
| Low GI | Active comparator | Other: Nutrition educationCarbohydrate foods with a low glycemic index. Low GI rice and whole grain bread provided to subjects if they wish. Subjects are provided with a list of recommended foods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Attending Mt. Sinai Maternal Fetal Medicine Unit
- Any ONE of: body mass index >=25 kg/m^2
- OR age >=35 years
- OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)
Key exclusion criteria (4 listed)
- Have pre-existing diabetes (type 1 or type 2) before becoming pregnant
- Acute or chronic illness which may affect carbohydrate metabolism
- Language/literacy barriers which cannot be overcome via available resources
- >16 weeks gestation
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 |
|---|---|---|
| Nutrition educationGroup nutrition classes supplemented by handouts and provision of key study foods. | Other | High fiber, Low GI |
Primary outcome
Serum glucose concentration 1hr after glucose challenge test
Time frame: 26 weeks gestation
11 secondary outcomes
GCT outcome
Time frame: 26 weeks gestation
GDM outcome
Time frame: 26 weeks gestation
Maternal weight
Time frame: At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation
Mode of delivery
Time frame: At time of birth of baby
Presence of birth trauma
Time frame: At time of birth of baby
Weight of baby
Time frame: At time of birth of baby
Presence of macrosomia
Time frame: At time of birth of baby
presence of large for gestational age baby
Time frame: At time of birth of baby
Presence of small for gestational age baby
Time frame: At time of birth of baby
food frequency questionnaire
Time frame: at 12 weeks and 26 weeks gestation
Acceptability of study foods
Time frame: 26 weeks gestation
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 12 Mar 2013.
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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, BM, BCh, 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 study testing Nutrition education in people with Diabetes, Gestational, 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 4 inclusion and 4 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 12 Mar 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Serum glucose concentration 1hr after glucose challenge test (time frame: 26 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2013.