NCT06442150Not yet recruiting
LCMD for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
Source: ClinicalTrials.gov · Last updated 4 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 17 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT06442150
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 1 Jun 2024 to the primary completion date, 30 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- 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)
Other
- Severe arthritis or active gout
- Pregnancy, lactation, or planned conception during the study
- Substance abuse
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Municipal Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.