Clinical trial NCT05710900: DiEt ChoIce to Promote Type 2 Diabetes REmission
Official title: DECIDE: DiEt ChoIce to Promote Type 2 Diabetes REmission Supported by Community Pharmacists and Registered Dietitians
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: low-carbohydrate diets
low-calorie diets
type 2 diabetes remission
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot implementation study
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Dual criteria for adherence to dietary interventions
timeFrame: 52 weeks
measure: Intervention preference
timeFrame: 52 weeks
measure: Type 2 diabetes remission
timeFrame: 52 weeks
Secondary outcomes:
measure: Body mass
timeFrame: weeks 0,12 ,20, 39, 52
measure: Body mass index
timeFrame: weeks 0,12 ,20, 39, 52
measure: Waist circumference
timeFrame: weeks 0,12 ,20, 39, 52
measure: Blood pressure
timeFrame: weeks 0,12 ,20, 39, 52
measure: Hemoglobin A1c
timeFrame: weeks 0,12 ,20, 39, 52
measure: Fasting plasma glucose
timeFrame: weeks 0,12 ,20, 39, 52
measure: Blood lipids
timeFrame: weeks 0,12 ,20, 39, 52
measure: Liver enzymes
timeFrame: weeks 0,12 ,20, 39, 52
measure: C-reactive protein
timeFrame: weeks 0,12 ,20, 39, 52
measure: Creatinine
timeFrame: weeks 0,12 ,20, 39, 52
measure: 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.
timeFrame: weeks 0,12 ,20, 39, 52
measure: Hemoglobin A1c by finger pricks - only LCal group
timeFrame: weeks 0,12 ,20, 39, 52
measure: Diabetes medication
timeFrame: weeks 0,12 ,20, 39, 52
measure: Anti-hypertensive medication
timeFrame: weeks 0,12 ,20, 39, 52
measure: Physical activity questionnaire
timeFrame: weeks 0,12 ,20, 39, 52
measure: Sleep quality questionnaire
timeFrame: weeks 0,12 ,20, 39, 52
measure: Hunger and satiety
timeFrame: weeks 0,12 ,20, 39, 52
measure: Quality of life
timeFrame: weeks 0,12 ,20, 39, 52
measure: 2-hour postprandial hyperglycemia
timeFrame: weeks 0,12 ,20, 39, 52
measure: 24hr average glucose area under the curve (AUC)
timeFrame: weeks 0,12 ,20, 39, 52
measure: Fasting glucose
timeFrame: weeks 0,12 ,20, 39, 52
measure: Glycemic variability
timeFrame: weeks 0,12 ,20, 39, 52
measure: Time in target range
timeFrame: weeks 0,12 ,20, 39, 52
measure: Glucose management indicator (GMI)
timeFrame: weeks 0,12 ,20, 39, 52
measure: Self-reported energy consumption
timeFrame: weeks 1,12 ,20, 39, 52
measure: Theory of planned behavior
timeFrame: weeks 0 and 52
measure: Binge eating scale
timeFrame: weeks 0 and 52
measure: Self-esteem scale
timeFrame: weeks 0 and 52
measure: Diet Habit
timeFrame: weeks 0 and 52
measure: Diet and food satisfaction
timeFrame: weeks 12 and 52
measure: Preliminary economic analysis
timeFrame: week 52
measure: Satisfaction, adherence and efficacy
timeFrame: week 52
measure: Feedback of the intervention with participants, RDs and pharmacists
timeFrame: week 52
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References: