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Active, Not Recruiting

NCT Number: NCT05710900

DiEt ChoIce to Promote Type 2 Diabetes rEmission

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dietary Intervention

Other

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 outcomes

  1. 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.

  2. Intervention preference

    Time frame: 52 weeks

    the proportion of participants choosing each intervention

  3. 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 outcomes

  1. 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

  2. Body mass index

    Time frame: weeks 0,12 ,20, 39, 52

    Calculated as kg/m2.

  3. 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

  4. 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

  5. Hemoglobin A1c

    Time frame: weeks 0,12 ,20, 39, 52

    Venous HbA1c (%) assessed in a clinical laboratory.

  6. Fasting plasma glucose

    Time frame: weeks 0,12 ,20, 39, 52

    Fasting plasma glucose (mmol/L) assessed in a clinical laboratory.

  7. 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.

  8. Liver enzymes

    Time frame: weeks 0,12 ,20, 39, 52

    Liver enzymes (ALT, AST, GGT) assessed in a clinical laboratory.

  9. C-reactive protein

    Time frame: weeks 0,12 ,20, 39, 52

    CRP (mg/L) assessed in a clinical laboratory.

  10. 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).

  11. 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.

  12. 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.

  13. Diabetes medication

    Time frame: weeks 0,12 ,20, 39, 52

    Type and dosage of medication.

  14. Anti-hypertensive medication

    Time frame: weeks 0,12 ,20, 39, 52

    Type and dosage of medication.

  15. Physical activity questionnaire

    Time frame: weeks 0,12 ,20, 39, 52

    Physical activity will be assessed by the GODIN Questionnaire.

  16. Sleep quality questionnaire

    Time frame: weeks 0,12 ,20, 39, 52

    Sleep will be assessed by the Pittsburg Sleep Quality Index (PSQI) questionnaire.

  17. Hunger and satiety

    Time frame: weeks 0,12 ,20, 39, 52

    Hunger and satiety assessed by a hunger/fullness Visual Analogue Scale (VAS) questionnaire.

  18. Quality of life

    Time frame: weeks 0,12 ,20, 39, 52

    Quality of life assessed by a self-rated health questionnaire (EQ-5D-5L).

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. Theory of planned behavior

    Time frame: weeks 0 and 52

    Theory of planned behavior assessed by • Theory of planned behavior (TPB) questionnaire.

  27. Binge eating scale

    Time frame: weeks 0 and 52

    Binge eating scale assessed by a 16-item self-report questionnaire.

  28. Self-esteem scale

    Time frame: weeks 0 and 52

    Self-esteem scale assessed by a 10-item scale questionnaire.

  29. Diet Habit

    Time frame: weeks 0 and 52

    Diet habit assessed by a diet habit questionnaire.

  30. Diet and food satisfaction

    Time frame: weeks 12 and 52

    Diet and food satisfaction assessed by a survey.

  31. 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);

  32. 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.

  33. 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: DECIDE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2023
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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