Clinical trial

LCMD for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences

Opening soon · Not applicable · 1 countries · Registry ID NCT06442150

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus in Obese, Type 2 Diabetes

Full registry criteria

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

Treatments and study arms

Low-Calorie Medicine Diet

Combination Product

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

Combination Product

Low-Calorie Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.

Primary outcomes

Number of participants achieving diabetes remission as assessed by American Diabetes Association criteriaBaseline 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 weightBaseline to 12, 24 and 52 weeks

Proportion of participants achieving significant weight loss (≥12kg/10kg).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Shanghai Municipal Hospital of Traditional Chinese Medicine🇨🇳 Shanghai, Shanghai Municipality, China