Type 2 DiabetesDECIDENCT05710900
DiEt ChoIce to Promote Type 2 Diabetes rEmission
A study testing Dietary intervention in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
Type 2 diabetes is typically viewed as a chronic, progressive, and lifelong condition. Patients and their healthcare providers "manage" type 2 diabetes through lifestyle modifications and various types of medications designed to lower blood sugar. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-80 years old
- 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.
Who cannot join
- History of heart disease, heart attack, heart failure, stroke or coronary artery disease within the previous 2 years,
- 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,
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 3G1
About this study
Official title: DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians
Type 2 diabetes is typically viewed as a chronic, progressive, and lifelong condition. Patients and their healthcare providers "manage" type 2 diabetes through lifestyle modifications and various types of medications designed to lower blood sugar.
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.
Read the detailed description
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). We will determine if there is a preference for one diet over the other, measure satisfaction with each approach, and determine clinical outcomes (T2D remission, medication use, blood biomarkers) at one year. Qualitative interviews and feedback surveys with the participants, pharmacists, and RD will provide information on barriers and facilitators to each T2D remission strategy.
- Conditions
- Type 2 Diabetes
- Being tested
- Dietary intervention
- Keywords
- low-carbohydrate diets, low-calorie diets, type 2 diabetes remission
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Low-calorie diet group | Experimental | 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. Receives: Other: Dietary intervention |
| Low-carbohydrate diet group | Experimental | 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. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual criteria for adherence to dietary interventions
defined as the proportion of participants attending ≥75% of visits with the pharmacist and/or registered dietitian (RD) and achieving at least 5% weight loss.
Measured: 52 weeks
Intervention preference
the proportion of participants choosing each intervention
Measured: 52 weeks
Type 2 diabetes remission
the proportion of participants achieving diabetes remission defined as Hemoglobin A1c (HbA1c) <6.5% and no glucose-lowering medications for at least 3 months, per international and new Canadian Clinical Practice Guidelines
Measured: 52 weeks
Secondary outcomes (33)
Body mass
weight (kg) measured in-person for the LCal group and virtually for the LCarb group
Measured: weeks 0,12 ,20, 39, 52
Body mass index
Calculated as kg/m2.
Measured: weeks 0,12 ,20, 39, 52
Waist circumference
waist circumference (cm or in) measured in-person for the LCal group and virtually for the LCarb group
Measured: weeks 0,12 ,20, 39, 52
Blood pressure
Average of two blood pressure measurements in-person for the LCal group and virtually for the LCarb group
Measured: weeks 0,12 ,20, 39, 52
Hemoglobin A1c
Venous HbA1c (%) assessed in a clinical laboratory.
Measured: weeks 0,12 ,20, 39, 52
Fasting plasma glucose
Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.
Measured: weeks 0,12 ,20, 39, 52
Blood lipids
Blood lipids (total cholesterol, high-density cholesterol, low-density cholesterol, triglycerides, non-HDL cholesterol, cholesterol/HDL ratio) assessed in a clinical laboratory.
Measured: weeks 0,12 ,20, 39, 52
Liver enzymes
Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.
Measured: weeks 0,12 ,20, 39, 52
C-reactive protein
CRP (mg/L) assessed in a clinical laboratory.
Measured: weeks 0,12 ,20, 39, 52
Creatinine
Creatinine (mg/dL) assessed in a clinical laboratory to infer glomerular filtration rate (GFR - mL/min).
Measured: weeks 0,12 ,20, 39, 52
Hematology panel (White blood cell count (WBC), Red blood cell count (RBC), Platelet count, Hematocrit red blood cell volume (HCT), Hemoglobin concentration (HB), Differential white blood count, Red blood cell indices.
Hematology panel assessed in a clinical laboratory.
Measured: weeks 0,12 ,20, 39, 52
Hemoglobin A1c by finger pricks - only LCal group
Capillary HbA1c (%) assessed in pharmacies by point-of-care equipment.
Measured: weeks 0,12 ,20, 39, 52
Diabetes medication
Type and dosage of medication.
Measured: weeks 0,12 ,20, 39, 52
Anti-hypertensive medication
Type and dosage of medication.
Measured: weeks 0,12 ,20, 39, 52
Physical activity questionnaire
Physical activity will be assessed by the GODIN Questionnaire.
Measured: weeks 0,12 ,20, 39, 52
Sleep quality questionnaire
Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.
Measured: weeks 0,12 ,20, 39, 52
Hunger and satiety
Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.
Measured: weeks 0,12 ,20, 39, 52
Quality of life
Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).
Measured: weeks 0,12 ,20, 39, 52
2-hour postprandial hyperglycemia
2-hour postprandial hyperglycemia measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Measured: weeks 0,12 ,20, 39, 52
24hr average glucose area under the curve (AUC)
24hr average glucose area under the curve (AUC) measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Measured: weeks 0,12 ,20, 39, 52
Fasting glucose
Fasting glucose measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Measured: weeks 0,12 ,20, 39, 52
Glycemic variability
Glycemic variability measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Measured: weeks 0,12 ,20, 39, 52
Time in target range
Time in target range measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Measured: weeks 0,12 ,20, 39, 52
Glucose management indicator (GMI)
Glucose management indicator (GMI) measured and calculated by flash or continuous glucose monitoring for 14 days at each timepoint.
Measured: weeks 0,12 ,20, 39, 52
Self-reported energy consumption
Self-reported energy consumption will be assessed by 3-day food records at each timepoint.
Measured: weeks 1,12 ,20, 39, 52
Theory of planned behavior
Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.
Measured: weeks 0 and 52
Binge eating scale
Binge eating scale assessed by a 16-item self-report questionnaire.
Measured: weeks 0 and 52
Self-esteem scale
Self-esteem scale assessed by a 10-item scale questionnaire.
Measured: weeks 0 and 52
Diet Habit
Diet habit assessed by a diet habit questionnaire.
Measured: weeks 0 and 52
Diet and food satisfaction
Diet and food satisfaction assessed by a survey.
Measured: weeks 12 and 52
Preliminary economic analysis
Assessed by costs of intervention against anticipated cost reductions based on medication use and health improvements (i.e. EQ-5D-5L);
Measured: week 52
Satisfaction, adherence and efficacy
Satisfaction, adherence and efficacy will be assessed by a compilation of information: questionnaires, diet records, attendance to visits, weight loss, achievement of diabetes remission.
Measured: week 52
Feedback of the intervention with participants, RDs and pharmacists
Feedback of the intervention through interviews/surveys with participants, RDs and pharmacists
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Jul 2023
- Primary completion26 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot implementation study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710900
- Sponsor's protocol ID
- H22-03055
- Acronym
- DECIDE
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians
- ClinicalTrials.gov ID
- NCT05710900
- Acronym / sponsor ID
- DECIDE / H22-03055
- Conditions
- Type 2 Diabetes
- Keywords
- low-carbohydrate diets, low-calorie diets, type 2 diabetes remission
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 2 Feb 2023 (actual)
- 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.
Type 2 diabetes is typically viewed as a chronic, progressive, and lifelong condition. Patients and their healthcare providers "manage" type 2 diabetes through lifestyle modifications and various types of medications designed to lower blood sugar.
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.
Detailed description
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). We will determine if there is a preference for one diet over the other, measure satisfaction with each approach, and determine clinical outcomes (T2D remission, medication use, blood biomarkers) at one year. Qualitative interviews and feedback surveys with the participants, pharmacists, and RD will provide information on barriers and facilitators to each T2D remission strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot implementation study
| Arm | Type | Receives |
|---|---|---|
| Low-calorie diet group | Experimental | Other: Dietary interventionA 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. |
| Low-carbohydrate diet group | Experimental | Other: Dietary interventionThe low-carbohydrate diet will involve an individualized whole-food diet (30-130 grams carbohydrate per day) led through virtual visits with a registered dietitian. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20-80 years old
- 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.
Key exclusion criteria (14 listed)
- History of heart disease, heart attack, heart failure, stroke or coronary artery disease within the previous 2 years,
- 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,
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 |
|---|---|---|
| Dietary interventionEach 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). | Other | Low-calorie diet group, Low-carbohydrate diet group |
Primary outcome
Dual criteria for adherence to dietary interventions
Time frame: 52 weeks
defined as the proportion of participants attending ≥75% of visits with the pharmacist and/or registered dietitian (RD) and achieving at least 5% weight loss.
Intervention preference
Time frame: 52 weeks
the proportion of participants choosing each intervention
Type 2 diabetes remission
Time frame: 52 weeks
the proportion of participants achieving diabetes remission defined as Hemoglobin A1c (HbA1c) <6.5% and no glucose-lowering medications for at least 3 months, per international and new Canadian Clinical Practice Guidelines
33 secondary outcomes
Body mass
Time frame: weeks 0,12 ,20, 39, 52
Body mass index
Time frame: weeks 0,12 ,20, 39, 52
Waist circumference
Time frame: weeks 0,12 ,20, 39, 52
Blood pressure
Time frame: weeks 0,12 ,20, 39, 52
Hemoglobin A1c
Time frame: weeks 0,12 ,20, 39, 52
Fasting plasma glucose
Time frame: weeks 0,12 ,20, 39, 52
Blood lipids
Time frame: weeks 0,12 ,20, 39, 52
Liver enzymes
Time frame: weeks 0,12 ,20, 39, 52
C-reactive protein
Time frame: weeks 0,12 ,20, 39, 52
Creatinine
Time frame: weeks 0,12 ,20, 39, 52
Hematology panel (White blood cell count (WBC), Red blood cell count (RBC), Platelet count, Hematocrit red blood cell volume (HCT), Hemoglobin concentration (HB), Differential white blood count, Red blood cell indices.
Time frame: weeks 0,12 ,20, 39, 52
Hemoglobin A1c by finger pricks - only LCal group
Time frame: weeks 0,12 ,20, 39, 52
Diabetes medication
Time frame: weeks 0,12 ,20, 39, 52
Anti-hypertensive medication
Time frame: weeks 0,12 ,20, 39, 52
Physical activity questionnaire
Time frame: weeks 0,12 ,20, 39, 52
Sleep quality questionnaire
Time frame: weeks 0,12 ,20, 39, 52
Hunger and satiety
Time frame: weeks 0,12 ,20, 39, 52
Quality of life
Time frame: weeks 0,12 ,20, 39, 52
2-hour postprandial hyperglycemia
Time frame: weeks 0,12 ,20, 39, 52
24hr average glucose area under the curve (AUC)
Time frame: weeks 0,12 ,20, 39, 52
Fasting glucose
Time frame: weeks 0,12 ,20, 39, 52
Glycemic variability
Time frame: weeks 0,12 ,20, 39, 52
Time in target range
Time frame: weeks 0,12 ,20, 39, 52
Glucose management indicator (GMI)
Time frame: weeks 0,12 ,20, 39, 52
Self-reported energy consumption
Time frame: weeks 1,12 ,20, 39, 52
Theory of planned behavior
Time frame: weeks 0 and 52
Binge eating scale
Time frame: weeks 0 and 52
Self-esteem scale
Time frame: weeks 0 and 52
Diet Habit
Time frame: weeks 0 and 52
Diet and food satisfaction
Time frame: weeks 12 and 52
Preliminary economic analysis
Time frame: week 52
Satisfaction, adherence and efficacy
Time frame: week 52
Feedback of the intervention with participants, RDs and pharmacists
Time frame: week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Type 2 Diabetes, run by University of British Columbia 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Dual criteria for adherence to dietary interventions (time frame: 52 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?
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 27 Jul 2026.