The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in gut microbiome profile
研究概览
简要总结
Food plays a crucial role in determining blood glucose levels, especially in people with type 2 diabetes. Precision nutrition, which involves individually tailored dietary interventions, can be a powerful tool in managing blood glucose levels in people with type 2 diabetes. Previous studies found that changes in gut microbiota resulted from the dietary intervention, such as plant-based diet, might subsequently lead to different glycemic responses, and then different health outcomes.
In this study, the investigators will characterize the blood glucose dynamics and gut microbiota of individuals with type 2 diabetes. They aim to assess the influence of plant-based diet on gut microbiota; they will also investigate the influence of gut microbiota on glycemic responses. Additionally, a series of individual N-of-1 trails will be integrated to compare the effects of a white bread breakfast and a whole wheat bread breakfast on glucose metabolism at the individual level.
详细描述
Choice of design: The study is a two-arm intervention study integrated with N-of-1 design.
Study population: Patients with type 2 diabetes.
Screening Assessment: Prospective participants will be selected based on the pre-defined inclusion and exclusion criteria. Recruitment will be done over the phone and via the social media.
Study duration: Each participant will take part in the study for a period of up to 1 month at baseline and have follow-up visits every 1-2 years.
Dietary intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes;
- •Living in Hangzhou for at least five years;
- •Have the willingness or ability to complete the intervention and sample collection
排除标准
- •Mental and physical disability;
- •Already is a vegetarian;
- •Cancer and serious complications from type 2 diabetes, such as renal failure;
- •Using insulin for more than 5 years;
- •Unstable medical/medication status;
- •Current alcohol or drug abuse;
- •Taking antibiotics in the last three months
研究组 & 干预措施
Conventional diabetic diet
Participants in this arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: Follow-up visit every 1-2 years (Other)
Plant-based diet
Participants in this arm will be recommended to consume more fiber-rich foods, including whole grains, fruits, legumes and vegetables; to moderate their intake of fish, eggs and dairy products; and to avoid other animal products. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: White bread (Other)
Plant-based diet
Participants in this arm will be recommended to consume more fiber-rich foods, including whole grains, fruits, legumes and vegetables; to moderate their intake of fish, eggs and dairy products; and to avoid other animal products. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: Whole wheat bread (Other)
Plant-based diet
Participants in this arm will be recommended to consume more fiber-rich foods, including whole grains, fruits, legumes and vegetables; to moderate their intake of fish, eggs and dairy products; and to avoid other animal products. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: Plant-based diet (Behavioral)
Plant-based diet
Participants in this arm will be recommended to consume more fiber-rich foods, including whole grains, fruits, legumes and vegetables; to moderate their intake of fish, eggs and dairy products; and to avoid other animal products. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: Follow-up visit every 1-2 years (Other)
Conventional diabetic diet
Participants in this arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: White bread (Other)
Conventional diabetic diet
Participants in this arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: Whole wheat bread (Other)
Conventional diabetic diet
Participants in this arm will be recommended to have a diet following 2023 Chinese Diabetes Society guidelines. All participants are instructed not to modify their exercise habits during the intervention period.
干预措施: Conventional diabetic diet (Other)
结局指标
主要结局
Changes in gut microbiome profile
时间窗: Day 1 and Day 31
Shotgun metagenomic sequencing will be performed in stool samples.
Blood glucose profile
时间窗: 2 weeks
Real-time blood glucose fluctuations will be recorded using continuous glucose monitoring.
次要结局
- Number of participants with chronic kidney disease(Up to 10 years)
- Changes in fasting blood glucose(Day 1 and Day 31)
- Changes in fasting blood HbA1c(Day 1 and Day 31)
- Changes in lipid metabolism(Day 1 and Day 31)
- Carotid plaque(At enrollment)
- Carotid intima-media thickness(At enrollment)
- Cognitive function(Up to 10 years)
- Changes in fasting blood C-peptide(Day 1 and Day 31)