DiEt ChoIce to Promote Type 2 Diabetes rEmission

Overview

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.

Full Title of Study: “DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 15, 2025

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • Body mass index
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Calculated as kg/m2.
  • 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
  • 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
  • Hemoglobin A1c
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Venous HbA1c (%) assessed in a clinical laboratory.
  • Fasting plasma glucose
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.
  • 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.
  • Liver enzymes
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.
  • C-reactive protein
    • Time Frame: weeks 0,12 ,20, 39, 52
    • CRP (mg/L) assessed in a clinical laboratory.
  • 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).
  • 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.
  • 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.
  • Diabetes medication
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Type and dosage of medication.
  • Anti-hypertensive medication
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Type and dosage of medication.
  • Physical activity questionnaire
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Physical activity will be assessed by the GODIN Questionnaire.
  • Sleep quality questionnaire
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.
  • Sleep activity
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Sleep will be assessed using an accelerometer (GENEActiv) worn for 14 days at each timepoint.
  • Hunger and satiety
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.
  • Quality of life
    • Time Frame: weeks 0,12 ,20, 39, 52
    • Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Theory of planned behavior
    • Time Frame: weeks 0 and 52
    • Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.
  • Binge eating scale
    • Time Frame: weeks 0 and 52
    • Binge eating scale assessed by a 16-item self-report questionnaire.
  • Self-esteem scale
    • Time Frame: weeks 0 and 52
    • Self-esteem scale assessed by a 10-item scale questionnaire.
  • Diet Habit
    • Time Frame: weeks 0 and 52
    • Diet habit assessed by a diet habit questionnaire.
  • Diet and food satisfaction
    • Time Frame: weeks 12 and 52
    • Diet and food satisfaction assessed by a survey.
  • 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);
  • 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.
  • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jonathan Little, Professor – University of British Columbia
  • Overall Contact(s)
    • Barbara Oliveira, PhD, (250) 859-9900, barbara.oliveira@ubc.ca

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