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DiEt ChoIce to Promote Type 2 Diabetes rEmission (DECIDE)

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring low-carbohydrate diets, low-calorie diets, type 2 diabetes remission

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of British Columbia OkanaganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low-calorie diet group

Low-carbohydrate diet group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Intervention preference
the proportion of participants choosing each intervention
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

Secondary Outcome Measures

Body mass
weight (kg) measured in-person for the LCal group and virtually for the LCarb group
Body mass index
Calculated as kg/m2.
Waist circumference
waist circumference (cm or in) measured in-person for the LCal group and virtually for the LCarb group
Blood pressure
Average of two blood pressure measurements in-person for the LCal group and virtually for the LCarb group
Hemoglobin A1c
Venous HbA1c (%) assessed in a clinical laboratory.
Fasting plasma glucose
Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.
Blood lipids
Blood lipids (total cholesterol, high-density cholesterol, low-density cholesterol, triglycerides, non-HDL cholesterol, cholesterol/HDL ratio) assessed in a clinical laboratory.
Liver enzymes
Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.
C-reactive protein
CRP (mg/L) assessed in a clinical laboratory.
Creatinine
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.
Hematology panel assessed in a clinical laboratory.
Hemoglobin A1c by finger pricks - only LCal group
Capillary HbA1c (%) assessed in pharmacies by point-of-care equipment.
Diabetes medication
Type and dosage of medication.
Anti-hypertensive medication
Type and dosage of medication.
Physical activity questionnaire
Physical activity will be assessed by the GODIN Questionnaire.
Sleep quality questionnaire
Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.
Sleep activity
Sleep will be assessed using an accelerometer (GENEActiv) worn for 14 days at each timepoint.
Hunger and satiety
Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.
Quality of life
Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).
2-hour postprandial hyperglycemia
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)
24hr average glucose area under the curve (AUC) measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Fasting glucose
Fasting glucose measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Glycemic variability
Glycemic variability measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Time in target range
Time in target range measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Glucose management indicator (GMI)
Glucose management indicator (GMI) measured and calculated by flash or continuous glucose monitoring for 14 days at each timepoint.
Self-reported energy consumption
Self-reported energy consumption will be assessed by 3-day food records at each timepoint.
Theory of planned behavior
Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.
Binge eating scale
Binge eating scale assessed by a 16-item self-report questionnaire.
Self-esteem scale
Self-esteem scale assessed by a 10-item scale questionnaire.
Diet Habit
Diet habit assessed by a diet habit questionnaire.
Diet and food satisfaction
Diet and food satisfaction assessed by a survey.
Preliminary economic analysis
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
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
Feedback of the intervention through interviews/surveys with participants, RDs and pharmacists

Full Information

First Posted
January 16, 2023
Last Updated
October 23, 2023
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05710900
Brief Title
DiEt ChoIce to Promote Type 2 Diabetes rEmission
Acronym
DECIDE
Official Title
DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
low-carbohydrate diets, low-calorie diets, type 2 diabetes remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot implementation study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-calorie diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-carbohydrate diet group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention 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).
Primary Outcome Measure Information:
Title
Dual criteria for adherence to dietary interventions
Description
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
Title
Intervention preference
Description
the proportion of participants choosing each intervention
Time Frame
52 weeks
Title
Type 2 diabetes remission
Description
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
Secondary Outcome Measure Information:
Title
Body mass
Description
weight (kg) measured in-person for the LCal group and virtually for the LCarb group
Time Frame
weeks 0,12 ,20, 39, 52
Title
Body mass index
Description
Calculated as kg/m2.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Waist circumference
Description
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
Title
Blood pressure
Description
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
Title
Hemoglobin A1c
Description
Venous HbA1c (%) assessed in a clinical laboratory.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Fasting plasma glucose
Description
Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Blood lipids
Description
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
Title
Liver enzymes
Description
Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.
Time Frame
weeks 0,12 ,20, 39, 52
Title
C-reactive protein
Description
CRP (mg/L) assessed in a clinical laboratory.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Creatinine
Description
Creatinine (mg/dL) assessed in a clinical laboratory to infer glomerular filtration rate (GFR - mL/min).
Time Frame
weeks 0,12 ,20, 39, 52
Title
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.
Description
Hematology panel assessed in a clinical laboratory.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Hemoglobin A1c by finger pricks - only LCal group
Description
Capillary HbA1c (%) assessed in pharmacies by point-of-care equipment.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Diabetes medication
Description
Type and dosage of medication.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Anti-hypertensive medication
Description
Type and dosage of medication.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Physical activity questionnaire
Description
Physical activity will be assessed by the GODIN Questionnaire.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Sleep quality questionnaire
Description
Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Sleep activity
Description
Sleep will be assessed using an accelerometer (GENEActiv) worn for 14 days at each timepoint.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Hunger and satiety
Description
Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Quality of life
Description
Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).
Time Frame
weeks 0,12 ,20, 39, 52
Title
2-hour postprandial hyperglycemia
Description
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
Title
24hr average glucose area under the curve (AUC)
Description
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
Title
Fasting glucose
Description
Fasting glucose measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Glycemic variability
Description
Glycemic variability measured by flash or continuous glucose monitoring for 14 days at each timepoint.
Time Frame
weeks 0,12 ,20, 39, 52
Title
Time in target range
Description
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
Title
Glucose management indicator (GMI)
Description
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
Title
Self-reported energy consumption
Description
Self-reported energy consumption will be assessed by 3-day food records at each timepoint.
Time Frame
weeks 1,12 ,20, 39, 52
Title
Theory of planned behavior
Description
Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.
Time Frame
weeks 0 and 52
Title
Binge eating scale
Description
Binge eating scale assessed by a 16-item self-report questionnaire.
Time Frame
weeks 0 and 52
Title
Self-esteem scale
Description
Self-esteem scale assessed by a 10-item scale questionnaire.
Time Frame
weeks 0 and 52
Title
Diet Habit
Description
Diet habit assessed by a diet habit questionnaire.
Time Frame
weeks 0 and 52
Title
Diet and food satisfaction
Description
Diet and food satisfaction assessed by a survey.
Time Frame
weeks 12 and 52
Title
Preliminary economic analysis
Description
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
Title
Satisfaction, adherence and efficacy
Description
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
Title
Feedback of the intervention with participants, RDs and pharmacists
Description
Feedback of the intervention through interviews/surveys with participants, RDs and pharmacists
Time Frame
week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Oliveira, PhD
Phone
(250) 859-9900
Email
barbara.oliveira@ubc.ca
Facility Information:
Facility Name
University of British Columbia Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 3G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Little, PhD
Phone
2508079876
Email
jonathan.little@ubc.ca
Phone
2508079876
Email
jonathan.little@ubc.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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