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Dietary Intervention for Type 2 Diabetes (DECIDE Trial)
N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 20-80 years old
Diagnosed with T2D by a physician
Must not have
History of cancer within the previous 5 years
History of kidney disease with eGFR <30 mls/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1,12 ,20, 39, 52
Awards & highlights
Summary
This trial will look at people with type 2 diabetes to see if a low-calorie or low-carb diet can put them into remission, with no need for medication.
Who is the study for?
This trial is for adults aged 20-80 with Type 2 Diabetes, an HbA1c level of at least 6.0%, and a BMI over 27 kg/m2. Participants should be able to follow a low-calorie or low-carbohydrate diet without dietary restrictions and must have internet access. Those who've recently lost weight, had bariatric surgery, severe mental health issues, recent serious illnesses like cancer or heart disease, eating disorders, or are pregnant can't join.Check my eligibility
What is being tested?
The study explores whether Type 2 Diabetes can go into remission through diet alone—without medications. It compares the effectiveness of a low-calorie diet versus a low-carbohydrate diet on lowering blood sugar levels to normal ranges.See study design
What are the potential side effects?
Potential side effects from the dietary interventions may include nutritional deficiencies if not properly managed, changes in energy levels due to altered food intake, digestive changes such as constipation or diarrhea depending on the diet composition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 80 years old.
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I have been diagnosed with Type 2 Diabetes by a doctor.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer within the last 5 years.
Select...
My kidney function is low, with an eGFR under 30.
Select...
I have a history of neurological disease.
Select...
I have had weight loss surgery in the past.
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I have moderate or severe depression, anxiety, or a mental health condition that affects my daily life.
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I do not have any unstable heart conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1,12 ,20, 39, 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1,12 ,20, 39, 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dual criteria for adherence to dietary interventions
Intervention preference
Type 2 diabetes remission
Secondary outcome measures
2-hour postprandial hyperglycemia
24hr average glucose area under the curve (AUC)
Anti-hypertensive medication
+31 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Low-carbohydrate diet groupExperimental Treatment1 Intervention
The low-carbohydrate diet will involve an individualized whole-food diet (30-130 grams carbohydrate per day) led through virtual visits with a registered dietitian.
Group II: Low-calorie diet groupExperimental Treatment1 Intervention
A low-calorie diet involving will involve a commercial weight loss program (pre-packaged foods from Ideal Protein, select lean protein sources, non-starchy vegetables) and be led by the pharmacist and registered dietitian (RD) involving in-person and virtual appointments.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,431 Previous Clinical Trials
2,478,803 Total Patients Enrolled
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