DiEt ChoIce to Promote Type 2 Diabetes rEmission

Study Overview
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Brief Summary
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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
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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.

Official Title
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DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot implementation study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-calorie diet group<br>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<br>* 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).<br>|
| Experimental: Low-carbohydrate diet group<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 52 weeks | 
| Intervention preference | the proportion of participants choosing each intervention | 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 | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass | weight (kg) measured in-person for the LCal group and virtually for the LCarb group | weeks 0,12 ,20, 39, 52 | 
| Body mass index | Calculated as kg/m2. | 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 | 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 | weeks 0,12 ,20, 39, 52 | 
| Hemoglobin A1c | Venous HbA1c (%) assessed in a clinical laboratory. | weeks 0,12 ,20, 39, 52 | 
| Fasting plasma glucose | Fasting plasma glucose (mmol/L) assessed in a clinical laboratory. | 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. | weeks 0,12 ,20, 39, 52 | 
| Liver enzymes | Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory. | weeks 0,12 ,20, 39, 52 | 
| C-reactive protein | CRP (mg/L) assessed in a clinical laboratory. | weeks 0,12 ,20, 39, 52 | 
| Creatinine | 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. | Hematology panel assessed in a clinical laboratory. | weeks 0,12 ,20, 39, 52 | 
| Hemoglobin A1c by finger pricks - only LCal group | Capillary HbA1c (%) assessed in pharmacies by point-of-care equipment. | weeks 0,12 ,20, 39, 52 | 
| Diabetes medication | Type and dosage of medication. | weeks 0,12 ,20, 39, 52 | 
| Anti-hypertensive medication | Type and dosage of medication. | weeks 0,12 ,20, 39, 52 | 
| Physical activity questionnaire | Physical activity will be assessed by the GODIN Questionnaire. | weeks 0,12 ,20, 39, 52 | 
| Sleep quality questionnaire | Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire. | weeks 0,12 ,20, 39, 52 | 
| Sleep activity | Sleep will be assessed using an accelerometer (GENEActiv) worn for 14 days at each timepoint. | weeks 0,12 ,20, 39, 52 | 
| Hunger and satiety | Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire. | weeks 0,12 ,20, 39, 52 | 
| Quality of life | Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L). | 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. | 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. | weeks 0,12 ,20, 39, 52 | 
| Fasting glucose | Fasting glucose measured by flash or continuous glucose monitoring for 14 days at each timepoint. | weeks 0,12 ,20, 39, 52 | 
| Glycemic variability | 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 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) | 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 | 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 | Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire. | weeks 0 and 52 | 
| Binge eating scale | Binge eating scale assessed by a 16-item self-report questionnaire. | weeks 0 and 52 | 
| Self-esteem scale | Self-esteem scale assessed by a 10-item scale questionnaire. | weeks 0 and 52 | 
| Diet Habit | Diet habit assessed by a diet habit questionnaire. | weeks 0 and 52 | 
| Diet and food satisfaction | Diet and food satisfaction assessed by a survey. | 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); | 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. | week 52 | 
| Feedback of the intervention with participants, RDs and pharmacists | Feedback of the intervention through interviews/surveys with participants, RDs and pharmacists | week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-carbohydrate diets, low-calorie diets, type 2 diabetes remission