DiEt ChoIce to Promote Type 2 Diabetes rEmission

Type 2 Diabetes Clinical Trial

— DECIDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710900
• Other study ID #: H22-03055
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: October 2023
• Source: University of British Columbia
• Contact: Barbara Oliveira, PhD
• Phone: (250) 859-9900
• Email: barbara.oliveira[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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).

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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