Shanghai Municipal Hospital of Traditional Chinese Medicine
Phase
Not applicable
Started
2024-06-01
Last updated
2024-06-04
Condition(s) studied
Type 2 Diabetes Mellitus in ObeseType 2 Diabetes
Investigational drug(s) / intervention(s)
Low-Calorie Medicine DietLow-Calorie Diet
Low-Calorie Medicine Diet: Low-Calorie Medicine Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
Low-Calorie Diet: Low-Calorie Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria — 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 — Baseline to 12, 24 and 52 weeks Proportion of participants achieving significant weight loss (≥12kg/10kg).
Trial sites (1)
Facility
City
Region
Status
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai
Shanghai Municipality
More Shanghai Municipal Hospital of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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