Low-Calorie Medicine Diet Tested in Adults With Type 2 Diabetes
Tests a low-calorie diet with herbs in overweight or obese adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: LCMD for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT06442150, who can take part
Where in China
- Shanghai Municipal Hospital of Traditional Chinese MedicineShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Trial code
- NCT06442150
- Record updated
- 4 June 2024
- Original description
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.Read full original descriptionShow less
Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
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.
Inclusion: 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: 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; Previously diagnosed psychiatric disorders (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder), uncontrolled depression, or epilepsy; Concurrent enrollment in another clinical trial; Long-term use of antibiotics, corticosteroids, NSAIDs, or PPIs; Any condition causing fluid overload, such as heart failure or liver cirrhosis; Active gallstone disease or known as asymptomatic gallstones; Known malignancy; Comorbidities increasing dietary intervention risk (e.g., biliary disorders); Chronic gastrointestinal disorders affecting gut microbiota (e.g., ulcerative colitis); Type 1 diabetes, type 2 diabetes currently treated with insulin, or HbA1c ≥12%; Chronic kidney disease stage 3b or above (eGFR <30 mL/min/1.73m²); Severe hepatic impairment (ALT >2.5× ULN); Severe arthritis or active gout; Pregnancy, lactation, or planned conception during the study; Substance abuse; Inability to provide informed consent.