Feasibility and Impact of an Intensive Team-based Intervention on Type 2 Diabetes Reversal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.
研究概览
简要总结
To evaluate the feasibility of a 6-month multidisciplinary program to reverse type 2 diabetes using the Mediterranean diet, intermittent fasting and exercise.
详细描述
The morbidities associated with type 2 diabetes (Db2) are major, including cardiovascular and renal complications, but also cognitive impairment. Providing interventions targeting Db2 reversal has shown great potential to improve healthy aging.
A Db2 reversal clinic has been established at the Montreal Heart Institute's ÉPIC Center, with an approach based on the Mediterranean diet and exercise. First-year results showed a 0.6% decrease in Hb1Ac and an average weight loss at 3 months of 4.5 kg in diabetic patients. This improvement was maintained at 6 and 12 months. Although these results are encouraging, the literature in Db2 remission shows that a weight loss of 10 kg is the ideal goal.
Therefore, to offer the possibility of further metabolic improvement at 6 months, three interventions are proposed as additions to the current program: targeting ultra-processed food reduction, motivational coaching and intermittent fasting. The main objective of our pilot study is to determine the feasibility of this improved program in type 2 diabetic patients, aged 18 to 80 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The randomisation will be effectuated with the participant number only for the Intermittent Fasting Intervention.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Ability to give written consent, to use a smartphone application or complete an adherence/compliance diary, and use a blood glucose and blood pressure machine at home.
排除标准
- •All types of diabetes other than type 2
- •Taking the following glucose-lowering agents: insulin, sulfonylureas
- •BMI < 18,5 kg/m2
- •Unintentional weight loss of more than 10 kg in the past year
- •Moderate to severe retinopathy
- •Pregnant or nursing woman
- •Severe organ failure
- •Pathologies predisposing to gastrointestinal bleeding, untreated
- •Recent cholecystitis (3 months)
- •Antibiotic use in the past 3 months, or untreated active infection
- •Known impaired nutrient absorption
- •Uninvestigated new anemia or Hb < 110 g/100 mL
- •Currently following an intermittent or prolonged fasting protocol
- •Currently following a specific diet (vegan, celiac/gluten free, ketogenic)
- •Active diagnoses of psychiatric or neurological illness not controlled for at least 6 months
- •Taking, stopping or adjusting a medication in the last 3 months resulting in an active weight change.
研究组 & 干预措施
Mediterranean diet and Personalized training
36 participants will participate to the following lifestyle changes for 6 months:
Behavioral: Lifestyle changes Nutritional advice to progressively integrate a moderate-carbohydrate Mediterranean diet.
Personalized exercise prescription and training (3 times per week)
Personalized education and motivational interviewing
干预措施: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting (Behavioral)
Intermittent Fasting Intervention
Between 3 and 6 months, 24 participants (on a total of 36) will progressively integrate intermittent fasting 16:8 (5 times/week for 12 weeks) and 20:4 (2 times/week for 4 weeks)
干预措施: Moderate-carbohydrate Mediterranean diet, Personalized exercice prescription and training, Intermittent fasting (Behavioral)
结局指标
主要结局
Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.
时间窗: at 6 months after the start of the intervention
Total recruitment, recruitment rate, compliance and completion rate at 6 months after the start of the intervention
Feasibility of an intensive multidisciplinary program based on lifestyle changes in patients diagnosed with type 2 diabetes.
时间窗: at 3 months after the start of the intervention
Total recruitment, recruitment rate, compliance and completion rate at 3 months after the start of the intervention
次要结局
- Proportion of diabetic participants in complete remission of diabetes.(at 3 and 6 months of the start of the intervention)
- Evolution of the HOMA-IR between the start of the program, the middle of the intervention (3 months) and the end of the intervention (6 months).(at 3 and 6 months of the start of the intervention)
研究者
Louis Bherer
Director of Centre EPIC research lab
Montreal Heart Institute