DiEt ChoIce to Promote Type 2 Diabetes rEmission (DECIDE)

July 24, 2026 updated by: Jonathan Little, University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 3G1
        • University of British Columbia Okanagan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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).
Experimental: 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.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
52 weeks
Intervention preference
Time Frame: 52 weeks
the proportion of participants choosing each intervention
52 weeks
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
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: weeks 0,12 ,20, 39, 52
Calculated as kg/m2.
weeks 0,12 ,20, 39, 52
Hemoglobin A1c
Time Frame: weeks 0,12 ,20, 39, 52
Venous HbA1c (%) assessed in a clinical laboratory.
weeks 0,12 ,20, 39, 52
Fasting plasma glucose
Time Frame: weeks 0,12 ,20, 39, 52
Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.
weeks 0,12 ,20, 39, 52
Blood lipids
Time Frame: weeks 0,12 ,20, 39, 52
Blood lipids (total cholesterol, high-density cholesterol, low-density cholesterol, triglycerides, non-HDL cholesterol, cholesterol/HDL ratio) assessed in a clinical laboratory.
weeks 0,12 ,20, 39, 52
Liver enzymes
Time Frame: weeks 0,12 ,20, 39, 52
Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.
weeks 0,12 ,20, 39, 52
C-reactive protein
Time Frame: weeks 0,12 ,20, 39, 52
CRP (mg/L) assessed in a clinical laboratory.
weeks 0,12 ,20, 39, 52
Creatinine
Time Frame: weeks 0,12 ,20, 39, 52
Creatinine (mg/dL) assessed in a clinical laboratory to infer glomerular filtration rate (GFR - mL/min).
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
Hematology panel assessed in a clinical laboratory.
weeks 0,12 ,20, 39, 52
Hemoglobin A1c by finger pricks - only LCal group
Time Frame: weeks 0,12 ,20, 39, 52
Capillary HbA1c (%) assessed in pharmacies by point-of-care equipment.
weeks 0,12 ,20, 39, 52
Diabetes medication
Time Frame: weeks 0,12 ,20, 39, 52
Type and dosage of medication.
weeks 0,12 ,20, 39, 52
Anti-hypertensive medication
Time Frame: weeks 0,12 ,20, 39, 52
Type and dosage of medication.
weeks 0,12 ,20, 39, 52
Physical activity questionnaire
Time Frame: weeks 0,12 ,20, 39, 52
Physical activity will be assessed by the GODIN Questionnaire.
weeks 0,12 ,20, 39, 52
Sleep quality questionnaire
Time Frame: weeks 0,12 ,20, 39, 52
Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.
weeks 0,12 ,20, 39, 52
Hunger and satiety
Time Frame: weeks 0,12 ,20, 39, 52
Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.
weeks 0,12 ,20, 39, 52
Quality of life
Time Frame: weeks 0,12 ,20, 39, 52
Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).
weeks 0,12 ,20, 39, 52
2-hour postprandial hyperglycemia
Time Frame: weeks 0,12 ,20, 39, 52
2-hour postprandial hyperglycemia measured by flash or continuous glucose monitoring for 14 days at each timepoint.
weeks 0,12 ,20, 39, 52
24hr average glucose area under the curve (AUC)
Time Frame: weeks 0,12 ,20, 39, 52
24hr average glucose area under the curve (AUC) measured by flash or continuous glucose monitoring for 14 days at each timepoint.
weeks 0,12 ,20, 39, 52
Fasting glucose
Time Frame: weeks 0,12 ,20, 39, 52
Fasting glucose measured by flash or continuous glucose monitoring for 14 days at each timepoint.
weeks 0,12 ,20, 39, 52
Glycemic variability
Time Frame: weeks 0,12 ,20, 39, 52
Glycemic variability measured by flash or continuous glucose monitoring for 14 days at each timepoint.
weeks 0,12 ,20, 39, 52
Time in target range
Time Frame: weeks 0,12 ,20, 39, 52
Time in target range measured by flash or continuous glucose monitoring for 14 days at each timepoint.
weeks 0,12 ,20, 39, 52
Glucose management indicator (GMI)
Time Frame: weeks 0,12 ,20, 39, 52
Glucose management indicator (GMI) measured and calculated by flash or continuous glucose monitoring for 14 days at each timepoint.
weeks 0,12 ,20, 39, 52
Self-reported energy consumption
Time Frame: weeks 1,12 ,20, 39, 52
Self-reported energy consumption will be assessed by 3-day food records at each timepoint.
weeks 1,12 ,20, 39, 52
Theory of planned behavior
Time Frame: weeks 0 and 52
Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.
weeks 0 and 52
Binge eating scale
Time Frame: weeks 0 and 52
Binge eating scale assessed by a 16-item self-report questionnaire.
weeks 0 and 52
Self-esteem scale
Time Frame: weeks 0 and 52
Self-esteem scale assessed by a 10-item scale questionnaire.
weeks 0 and 52
Diet Habit
Time Frame: weeks 0 and 52
Diet habit assessed by a diet habit questionnaire.
weeks 0 and 52
Diet and food satisfaction
Time Frame: weeks 12 and 52
Diet and food satisfaction assessed by a survey.
weeks 12 and 52
Preliminary economic analysis
Time Frame: week 52
Assessed by costs of intervention against anticipated cost reductions based on medication use and health improvements (i.e. EQ-5D-5L);
week 52
Satisfaction, adherence and efficacy
Time Frame: week 52
Satisfaction, adherence and efficacy will be assessed by a compilation of information: questionnaires, diet records, attendance to visits, weight loss, achievement of diabetes remission.
week 52
Feedback of the intervention with participants, RDs and pharmacists
Time Frame: week 52
Feedback of the intervention through interviews/surveys with participants, RDs and pharmacists
week 52
Body mass
Time Frame: weeks 0,12 ,20, 39, 52
weight (kg) measured in-person for the LCal group and virtually for the LCarb group
weeks 0,12 ,20, 39, 52
Waist circumference
Time Frame: weeks 0,12 ,20, 39, 52
waist circumference (cm or in) measured in-person for the LCal group and virtually for the LCarb group
weeks 0,12 ,20, 39, 52
Blood pressure
Time Frame: weeks 0,12 ,20, 39, 52
Average of two blood pressure measurements in-person for the LCal group and virtually for the LCarb group
weeks 0,12 ,20, 39, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H22-03055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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