Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-07-15
2026-11-01
Brief Summary
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Exciting new research indicates that "remission" of type 2 diabetes - defined as returning blood sugar into the normal range without having to use medications - through therapeutic nutrition may be possible for many people living with the condition.
We will examine the preference, adherence and clinical results of a low-calorie diet or low-carbohydrate diet in type 2 diabetes remission rates.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low-calorie diet group
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.
Dietary intervention
Each dietary remission strategy involves three phases focused on weight loss and medication deprescribing (Phase 1: Weeks 0-12), transition to an individualized sustainable dietary pattern (Phase 2: Weeks 13-20), and weight loss/remission maintenance (Phase 3: Weeks 21-52).
Low-carbohydrate diet group
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.
Dietary intervention
Each dietary remission strategy involves three phases focused on weight loss and medication deprescribing (Phase 1: Weeks 0-12), transition to an individualized sustainable dietary pattern (Phase 2: Weeks 13-20), and weight loss/remission maintenance (Phase 3: Weeks 21-52).
Interventions
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Dietary intervention
Each dietary remission strategy involves three phases focused on weight loss and medication deprescribing (Phase 1: Weeks 0-12), transition to an individualized sustainable dietary pattern (Phase 2: Weeks 13-20), and weight loss/remission maintenance (Phase 3: Weeks 21-52).
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with T2D by a physician,
* HbA1c ≥ 6.0%,
* Body Mass Index ≥27 kg/m2 and
* No contraindications or dietary restrictions to following a low-carbohydrate/low-calorie diet.
Exclusion Criteria
* any current unstable cardiovascular disorder,
* history of liver disease,
* history of kidney disease with eGFR \<30 mls/min/1.73 m2,
* history of neurological disease,
* previous bariatric surgery,
* weight loss (≥5%) within the last six months
* currently pregnant or lactating, or planning on becoming pregnant within the next 12 months,
* history of cancer within the previous 5 years,
* dietary restrictions or allergies that would inhibit adherence to the intervention diet,
* history of eating disorders,
* moderate or severe depression, anxiety or mental health condition that impacts daily life,
* currently following a low-carbohydrate or low-calorie diet, and
* unable to access the Internet (for communication with research team and RD).
20 Years
80 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Jonathan Little
Professor
Locations
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University of British Columbia Okanagan
Kelowna, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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H22-03055
Identifier Type: -
Identifier Source: org_study_id
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