Effects of Traditional Chinese Medicine Fasting Therapy on Metabolism and the Relationship Between Therapy-Induced Beta-Hydroxybutyrate Elevation and Metabolic Improvement: A Retrospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,149
- 试验地点
- 1
- 主要终点
- Correlation between changes in serum beta-hydroxybutyrate (βHB) and changes in metabolic indicators
研究概览
简要总结
This is a retrospective study using existing medical records. The purpose is to learn how Traditional Chinese Medicine (TCM) fasting therapy affects metabolism. The study also examines whether a substance called beta-hydroxybutyrate (βHB), which is produced during fasting, is related to improvements in metabolic health.
The researchers will review records of patients who previously received TCM fasting therapy. Patients will be divided into three groups based on how much their βHB levels increased after therapy (low, medium, and high). The study will compare changes in metabolic health measures, such as body weight, BMI, waist size, blood pressure, blood sugar, and blood fats, before and after therapy. It will also analyze whether greater increases in βHB are linked to greater improvements in these metabolic measures, while taking into account factors like age, sex, and baseline BMI.
This study does not involve any new tests or treatments. It only uses data that already exist in patient records. The findings may help doctors better understand how TCM fasting therapy works and whether βHB could be a useful marker for guiding treatment in the future.
详细描述
Overall Objective:
The overall objective of this study is to investigate the correlation between the elevation of serum beta-hydroxybutyrate (βHB) after Traditional Chinese Medicine (TCM) fasting therapy and the improvement of metabolic indicators, and to clarify whether βHB can serve as a potential biomarker for the metabolic effects of TCM fasting therapy, thereby providing clinical evidence for the metabolic regulatory mechanism of TCM fasting therapy.
Specific Objectives:
Baseline characteristics analysis: Using a three-category approach, enrolled cases will be divided into low, medium, and high groups based on the degree of βHB elevation after TCM fasting therapy. Baseline demographic characteristics and metabolic indicators (body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices) will be compared among the three groups to identify the baseline characteristics of populations with different βHB responses.
Intervention effect evaluation: To compare the overall changes in the above metabolic indicators before and after TCM fasting therapy, and to evaluate the comprehensive improvement effect of TCM fasting therapy in patients with overweight/obesity and metabolism-related diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 72 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years or older at the time of receiving TCM fasting therapy.
- •Diagnosed with overweight/obesity or a metabolism-related condition (e.g., overweight/obesity, metabolic syndrome, type 2 diabetes mellitus, dyslipidemia, or hypertension).
- •Received a structured Traditional Chinese Medicine (TCM) fasting therapy at The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen).
- •Serum beta-hydroxybutyrate (βHB) levels were measured before and after TCM fasting therapy.
- •Availability of complete medical records containing baseline and post-therapy data on key metabolic indicators (body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices).
排除标准
- •Patients with incomplete medical records lacking essential baseline or post-therapy metabolic data.
- •Patients with severe comorbidities that could independently affect metabolic outcomes (e.g., active malignancy, severe hepatic or renal insufficiency, or uncontrolled endocrine disorders other than the conditions being studied).
- •Patients who received other concurrent interventions that could significantly confound metabolic outcomes during the study period.
- •Pregnant or lactating women.
- •Patients whose medical records explicitly indicate refusal of data use for research purposes.
结局指标
主要结局
Correlation between changes in serum beta-hydroxybutyrate (βHB) and changes in metabolic indicators
时间窗: Baseline and at completion of TCM fasting therapy, an average of 7 days
The primary outcome is the correlation between the change in serum beta-hydroxybutyrate (βHB) levels from baseline (before TCM fasting therapy) to completion of TCM fasting therapy (average 7 days) and the concurrent changes in key metabolic indicators (including body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices). This will be assessed using partial correlation analysis, controlling for baseline age, sex, and BMI.
Correlation between increase in serum beta-hydroxybutyrate (βHB) and improvement in metabolic indicators
时间窗: Baseline and post-intervention , an average of 7 days
The primary outcome is the correlation between the change in serum beta-hydroxybutyrate (βHB) levels from baseline to post-TCM fasting therapy and the concurrent changes in key metabolic indicators (including body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices). This will be assessed using partial correlation analysis, controlling for baseline age, sex, and BMI.
次要结局
未报告次要终点
研究者
Yan Ling
Resident Physician
The Seventh Affiliated Hospital of Sun Yat-sen University