Your session is about to expire
← Back to Search
Nutritional Intervention for Gestational Diabetes (SAGE Trial)
N/A
Recruiting
Led By Anne-Sophie Morisset, RD, PhD
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes from the 1st to the 3rd trimester
Awards & highlights
SAGE Trial Summary
This trial will test whether a nutritional intervention, based on the 2019 Canada's Food Guide, started in the first trimester of pregnancy, will improve glucose homeostasis in 60 pregnant women at risk of gestational diabetes mellitus (GDM).
Who is the study for?
This trial is for pregnant women under 14 weeks gestation, at risk of gestational diabetes due to factors like age (35+), certain ethnic backgrounds, high BMI (≥30 kg/m2), or a family history of type 2 diabetes. Women with eating disorders, pre-existing diabetes, other diseases affecting glucose metabolism, or on steroids can't join.Check my eligibility
What is being tested?
The study tests if starting a healthy eating program early in pregnancy can improve blood sugar control and reduce the risk of gestational diabetes. It involves dietitian sessions and support through web capsules and a private Facebook group compared to standard care.See study design
What are the potential side effects?
Since this intervention focuses on nutritional guidance rather than medication, side effects are minimal but may include changes in digestion or food preferences as dietary habits are altered.
SAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ changes from the 1st to the 3rd trimester
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes from the 1st to the 3rd trimester
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fasting plasma glucose
Secondary outcome measures
Beta-cell function index
Gestational Diabetes Mellitus diagnosis
Glycemic response
+3 moreSAGE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutritional InterventionExperimental Treatment1 Intervention
Intervention promoting healthy eating by a Registered Dietitian.
Group II: Standard CareActive Control1 Intervention
Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Intervention
2011
Completed Phase 3
~690
Find a Location
Who is running the clinical trial?
Laval UniversityOTHER
417 Previous Clinical Trials
172,122 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,267 Total Patients Enrolled
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
107,007 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I cannot communicate in French.I have a condition that affects my blood sugar or requires special diet treatment.Currently participating in a nutrition program.I am unable to understand and agree to the study's details.I am 14 weeks pregnant or less.I am at risk of gestational diabetes due to my age, ethnicity, BMI, medical or family history.I am currently taking corticosteroids.I have been diagnosed with an eating disorder in the past or currently.You are pregnant with one baby.I was diagnosed with diabetes in the first trimester of my pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Nutritional Intervention
- Group 2: Standard Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research experiment actively seeking participants?
"Accurate. As per the information hosted on clinicaltrials.gov, this medical trial has started to look for participants and is still active as of August 1st 2022; the study was first posted on June 30th 2022."
Answered by AI
How many participants have signed up to take part in this experiment?
"Indeed, information hosted on clinicaltrials.gov demonstrated that this medical trial is currently enrolling patients. This study was initially shared to the public on June 30th 2022 and its most recent update occured August 1st of the same year. 60 participants are required across one major location."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger