Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours
研究概览
简要总结
This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
- •HbA1c ≥ 7% and < 9%
- •Antidiabetic medication has been stable for at least 3 months before recruitment
- •Aged 35-70 years
- •Signed the informed consent form
排除标准
- •Treatment with insulin
- •Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
- •Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
- •Having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (eGFR ≤60 ml/min/1.73 m²)
- •Presence of cardiovascular events (e.g., myocardial infarction, stent placement, unstable angina, heart failure, cardiac dysfunction) or cerebrovascular diseases (e.g., intracerebral hemorrhage, ischemic stroke) within the past 6 months
- •Diagnosis of acute or chronic gastrointestinal diseases (e.g., ulcers), hyperthyroidism or hypothyroidism, uncontrolled hypertension, active malignancy not in remission, or other life-threatening diseases
- •Recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use
- •Unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids)
- •Pregnancy, breastfeeding, or planning pregnancy
- •Presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fMRI
- •Psychiatric disorders impairing cooperation
- •Expected poor compliance
- •Current or recent (within 4 weeks prior to study initiation) participation in other clinical trials
研究组 & 干预措施
optimized carbohydrate diet-washout-conventional diabetes diet
Group that starts with the optimized carbohydrate diet
干预措施: optimized carbohydrate diet (Other)
optimized carbohydrate diet-washout-conventional diabetes diet
Group that starts with the optimized carbohydrate diet
干预措施: conventional diabetes diet (Other)
conventional diabetes diet-washout-optimized carbohydrate diet
Group that starts with the conventional diabetes diet
干预措施: optimized carbohydrate diet (Other)
conventional diabetes diet-washout-optimized carbohydrate diet
Group that starts with the conventional diabetes diet
干预措施: conventional diabetes diet (Other)
结局指标
主要结局
Change in the average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours
时间窗: -2, 0, 10, 16, 18 and 28 weeks
Average incremental area under the curve (iAUC) of postprandial blood glucose over 3 hours will be measured at -2, 0, 10, 16, 18, and 28 weeks using the continuous glucose monitoring system.
次要结局
- Change in insulin sensitivity(Baseline, 12, 18 and 30 weeks)
- Change in HbA1c(Baseline, 12, 18 and 30 weeks)
- Change in other clinical biochemical indicators(Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks)
- Change in appetite(Baseline, 12, 18 and 30 weeks)
- Change in emotion(Baseline, 12, 18 and 30 weeks)
- Change in sleep quality(Baseline, 12, 18 and 30 weeks)
- Change in bowel habits(Baseline, 12, 18 and 30 weeks)
- Change in cardiopulmonary exercise testing performance(Baseline, 12, 18 and 30 weeks)
- Change in blood lipid profiles(Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks)
- Change in other parameters of Continuous Glucose Monitoring(-2, 0, 10, 16, 18 and 28 weeks)
- Change in blood glucose(Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks)
- Change in insulin and C peptide secretion(Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks)
- Change in anthropometry and body composition parameters(Baseline, 4, 8, 12, 18, 22, 26 and 30 weeks)
- Change in cognitive function and behavioral performance(Baseline, 12, 18 and 30 weeks)
研究者
Li Huating
Professor
Shanghai 6th People's Hospital