DECIDE: DiEt ChoIce to Promote Type 2 Diabetes rEmission Supported by Community Pharmacists and Registered Dietitians
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Intervention preference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Dietary intervention (Other)
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.
干预措施: Dietary intervention (Other)
结局指标
主要结局
Intervention preference
时间窗: 52 weeks
the proportion of participants choosing each intervention
Dual criteria for adherence to dietary interventions
时间窗: 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.
Type 2 diabetes remission
时间窗: 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
次要结局
- Body mass(weeks 0,12 ,20, 39, 52)
- Body mass index(weeks 0,12 ,20, 39, 52)
- Waist circumference(weeks 0,12 ,20, 39, 52)
- Blood pressure(weeks 0,12 ,20, 39, 52)
- Hemoglobin A1c(weeks 0,12 ,20, 39, 52)
- Fasting plasma glucose(weeks 0,12 ,20, 39, 52)
- Blood lipids(weeks 0,12 ,20, 39, 52)
- Liver enzymes(weeks 0,12 ,20, 39, 52)
- C-reactive protein(weeks 0,12 ,20, 39, 52)
- Creatinine(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.(weeks 0,12 ,20, 39, 52)
- Hemoglobin A1c by finger pricks - only LCal group(weeks 0,12 ,20, 39, 52)
- Diabetes medication(weeks 0,12 ,20, 39, 52)
- Anti-hypertensive medication(weeks 0,12 ,20, 39, 52)
- Physical activity questionnaire(weeks 0,12 ,20, 39, 52)
- Sleep quality questionnaire(weeks 0,12 ,20, 39, 52)
- Hunger and satiety(weeks 0,12 ,20, 39, 52)
- Quality of life(weeks 0,12 ,20, 39, 52)
- 2-hour postprandial hyperglycemia(weeks 0,12 ,20, 39, 52)
- 24hr average glucose area under the curve (AUC)(weeks 0,12 ,20, 39, 52)
- Fasting glucose(weeks 0,12 ,20, 39, 52)
- Glycemic variability(weeks 0,12 ,20, 39, 52)
- Time in target range(weeks 0,12 ,20, 39, 52)
- Glucose management indicator (GMI)(weeks 0,12 ,20, 39, 52)
- Self-reported energy consumption(weeks 1,12 ,20, 39, 52)
- Theory of planned behavior(weeks 0 and 52)
- Binge eating scale(weeks 0 and 52)
- Self-esteem scale(weeks 0 and 52)
- Diet Habit(weeks 0 and 52)
- Diet and food satisfaction(weeks 12 and 52)
- Preliminary economic analysis(week 52)
- Satisfaction, adherence and efficacy(week 52)
- Feedback of the intervention with participants, RDs and pharmacists(week 52)
研究者
Jonathan Little
Professor
University of British Columbia