DiEt ChoIce to Promote Type 2 Diabetes rEmission (DECIDE)

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: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Dietary intervention

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Oliveira, PhD; Phone Number: (250) 859-9900; Email: barbara.oliveira@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 3G1
      • Recruiting
      • University of British Columbia Okanagan
      • Contact: Jonathan Little, PhD; Phone Number: 2508079876; Email: jonathan.little@ubc.ca
      • Contact: Phone Number: 2508079876; Email: jonathan.little@ubc.ca

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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 index	Calculated as kg/m2.	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
Body mass	weight (kg) measured in-person for the LCal group and virtually for the LCarb group	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

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: low-carbohydrate diets; low-calorie diets; type 2 diabetes remission
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID 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