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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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).
University of British Columbia Okanagan
Kelowna, British Columbia, Canada
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.
Time frame: 52 weeks
Intervention preference
the proportion of participants choosing each intervention
Time frame: 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
Time frame: 52 weeks
Body mass
weight (kg) measured in-person for the LCal group and virtually for the LCarb group
Time frame: weeks 0,12 ,20, 39, 52
Body mass index
Calculated as kg/m2.
Time frame: 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
Time frame: 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
Time frame: weeks 0,12 ,20, 39, 52
Hemoglobin A1c
Venous HbA1c (%) assessed in a clinical laboratory.
Time frame: weeks 0,12 ,20, 39, 52
Fasting plasma glucose
Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.
Time frame: 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.
Time frame: weeks 0,12 ,20, 39, 52
Liver enzymes
Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.
Time frame: weeks 0,12 ,20, 39, 52
C-reactive protein
CRP (mg/L) assessed in a clinical laboratory.
Time frame: weeks 0,12 ,20, 39, 52
Creatinine
Creatinine (mg/dL) assessed in a clinical laboratory to infer glomerular filtration rate (GFR - mL/min).
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.
Hematology panel assessed in a clinical laboratory.
Time frame: weeks 0,12 ,20, 39, 52
Hemoglobin A1c by finger pricks - only LCal group
Capillary HbA1c (%) assessed in pharmacies by point-of-care equipment.
Time frame: weeks 0,12 ,20, 39, 52
Diabetes medication
Type and dosage of medication.
Time frame: weeks 0,12 ,20, 39, 52
Anti-hypertensive medication
Type and dosage of medication.
Time frame: weeks 0,12 ,20, 39, 52
Physical activity questionnaire
Physical activity will be assessed by the GODIN Questionnaire.
Time frame: weeks 0,12 ,20, 39, 52
Sleep quality questionnaire
Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.
Time frame: weeks 0,12 ,20, 39, 52
Hunger and satiety
Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.
Time frame: weeks 0,12 ,20, 39, 52
Quality of life
Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).
Time frame: 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.
Time frame: 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.
Time frame: weeks 0,12 ,20, 39, 52
Fasting glucose
Fasting glucose measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Time frame: weeks 0,12 ,20, 39, 52
Glycemic variability
Glycemic variability measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: weeks 1,12 ,20, 39, 52
Theory of planned behavior
Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.
Time frame: weeks 0 and 52
Binge eating scale
Binge eating scale assessed by a 16-item self-report questionnaire.
Time frame: weeks 0 and 52
Self-esteem scale
Self-esteem scale assessed by a 10-item scale questionnaire.
Time frame: weeks 0 and 52
Diet Habit
Diet habit assessed by a diet habit questionnaire.
Time frame: weeks 0 and 52
Diet and food satisfaction
Diet and food satisfaction assessed by a survey.
Time frame: 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);
Time frame: 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.
Time frame: week 52
Feedback of the intervention with participants, RDs and pharmacists
Feedback of the intervention through interviews/surveys with participants, RDs and pharmacists
Time frame: week 52
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