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Completed
NCT07840807
Traditional Chinese Medicine Fasting Therapy, Ketone Levels, and Metabolic Improvements
Conditions: Obesity & Overweight, Diabete Type 2, Metabolic Syndrome
Sex: All
Ages: 14 Years – 72 Years
Healthy volunteers: No
Enrollment: 1149
Sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University
Location: The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen) Shenzhen Guangdong
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07840807). StuddyBuddy aggregates publicly available trial information.