Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria
研究概览
简要总结
Type 2 diabetes (T2DM) has become a major public health problem. Achieving remission (HbA1c<6.5% without glucose-lowering medications) has recently become a new treatment goal. Low-calorie diets effectively induce remission, but adverse effects like fatigue, appetite, and constipation hinder success. Integrating traditional Chinese medicine (TCM) herbs into a low-calorie diet may alleviate adverse effects and improve remission rates.
This project investigates the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving T2DM remission among overweight/obese individuals through a randomized controlled trial. The investigators will explore individual differences in remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating nutrition and TCM dietetics, this project provides a novel, evidence-based approach to managing T2DM in Chinese populations.
详细描述
Type 2 diabetes (T2DM) has become a major public health problem, and effective prevention and treatment strategies are urgently needed. Recently, the understanding of T2DM has shifted to "a disease that can be remission." Achieving remission, defined as HbA1c<6.5% without using glucose-lowering medications, has become a new treatment goal for T2DM. Evidence suggests that a low-calorie diet is an effective approach to induce remission. Our previous research (NCT05472272) also demonstrated that a low-calorie diet can achieve remission in Chinese T2DM patients.
However, adverse effects during the intervention, such as fatigue, appetite, and constipation, have become significant barriers to successful remission. These symptoms often result in poor adherence to the intervention plan and, consequently, failure to achieve remission. In traditional Chinese medicine (TCM), fatigue and constipation are typical symptoms of "Qi Vacuity", while hunger is more associated with "Yin Vacuity". "Herb is the food" is a unique concept in TCM. Integrating TCM herbs into a low-calorie diet may help alleviate these adverse effects and improve the likelihood of achieving diabetes remission.
This project aims to investigate the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving remission of T2DM among overweight/obese individuals through a randomized controlled trial. The investigators will also explore individual differences in achieving remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating theories from nutrition and TCM dietetics, this project seeks to provide a novel, evidence-based approach to the management of T2DM in Chinese populations.
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
Due to the unique nature of the intervention, it is not feasible to mask the participants and investigators in the treatment allocation. However, the outcomes assessor will be blinded to minimize potential bias in data analysis.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed T2DM
- •The history of T2DM less than 6 years
- •Most recent HbA1c higher than 6.5%
- •Body mass index: 24-45 kg/m2
- •Fasting C-p ≥1.1 ng/ml
- •Inability to provide informed consent
排除标准
- •Type 1 diabetes, type 2 diabetes currently treated with insulin, or HbA1c ≥12%
- •Cardiovascular events within 6 months before trial
- •Current use of anti-obesity medications, eating disorders, dieting behaviors, or weight loss >5 kg within 6 months before trial
- •Chronic kidney disease stage 3b or above (eGFR <30 mL/min/1.73m²)
- •Any condition causing fluid overload, such as heart failure or liver cirrhosis
- •Previously diagnosed psychiatric disorders (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder), uncontrolled depression, or epilepsy
- •Severe arthritis or active gout
- •Active gallstone disease or known as asymptomatic gallstones
- •Concurrent enrollment in another clinical trial
- •Pregnancy, lactation, or planned conception during the study
- •Substance abuse
- •Known malignancy
- •Comorbidities increasing dietary intervention risk (e.g., biliary disorders)
- •Long-term use of antibiotics, corticosteroids, NSAIDs, or PPIs
- •Chronic gastrointestinal disorders affecting gut microbiota (e.g., ulcerative colitis)
- •Severe hepatic impairment (ALT >2.5× ULN)
- •Inability to provide informed consent
结局指标
主要结局
Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria
时间窗: Baseline to 24 and 52 weeks
The proportion of participants achieving diabetes remission, which is defined as having a glycated hemoglobin (HbA1c) level less than 6.5% while receiving no pharmacological therapy for diabetes for at least 3 months.
Number of participants achieving significant weight loss, defined as a reduction of at least 12kg from baseline body weight
时间窗: Baseline to 12, 24 and 52 weeks
Proportion of participants achieving significant weight loss (≥12kg/10kg).
次要结局
- Change from baseline in liver fat content and pancreatic fat content as assessed by magnetic resonance imaging(Baseline to 12, 24 and 52 weeks)
- Change from baseline in brain functional connectivity and activity as assessed by functional magnetic resonance imaging(Baseline to 12, 24 and 52 weeks)
- Change from baseline in fasting serum lipid levels, including total cholesterol, LDL-C, HDL-C, and triglycerides(Baseline to 12, 24 and 52 weeks)
- Change from baseline in gut microbiota composition and its metabolites as assessed by 16S rRNA gene sequencing and metabolomics analysis(Baseline to 12, 24 and 52 weeks)
- Change from baseline in the quality of life score as assessed by a validated questionnaire (e.g., SF-36, EQ-5D)(Baseline to 12, 24 and 52 weeks)
- Change from baseline in insulin sensitivity as assessed by insulin tolerance test(Baseline to 12, 24 and 52 weeks)
- Change from baseline in beta cell function as assessed by arginine stimulation test(Baseline to 12, 24 and 52 weeks)
- Change from baseline in plasma glucose concentration(Baseline to 12, 24 and 52 weeks)
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)(12, 24 and 52 weeks)
研究者
Feng Tao
Director of Endocrinology
Shanghai Municipal Hospital of Traditional Chinese Medicine