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

Launched by SHANGHAI MUNICIPAL HOSPITAL OF TRADITIONAL CHINESE MEDICINE · May 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach called the Low-Calorie Medicine Diet (LCMD) for people with Type 2 diabetes (T2DM) who are overweight or obese. The main goal is to help participants achieve remission, which means getting their blood sugar levels under control without needing diabetes medications. The study will also look at how different people respond to the diet and explore how the brain, gut, and bacteria in our bodies work together in relation to diabetes. By combining a low-calorie diet with traditional Chinese medicine herbs, the researchers hope to make the diet easier to follow and improve the chances of success.

To be eligible for this trial, participants should be adults aged between 65 and 74 with a confirmed diagnosis of Type 2 diabetes for less than six years and have a recent blood sugar level (measured by HbA1c) higher than 6.5%. They should also have a body mass index (BMI) between 24 and 45. However, individuals with certain health conditions, such as Type 1 diabetes, recent heart problems, or those currently using specific medications, may not qualify. Participants can expect to follow a low-calorie diet and may receive additional support from herbal treatments throughout the study. This trial is not yet recruiting participants, but it represents a promising step toward better diabetes management.

Gender

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Eligibility 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