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

NCT ID: NCT06442150

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2027-11-30

Brief 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.

Detailed Description

Type 2 diabetes (T2DM) has become a major public health problem, and effective prevention and treatment strategies are urgently needed. Recently, the understanding of T2DM has shifted to "a disease that can be remission." Achieving remission, defined as HbA1c<6.5% without using glucose-lowering medications, has become a new treatment goal for T2DM. Evidence suggests that a low-calorie diet is an effective approach to induce remission. Our previous research (NCT05472272) also demonstrated that a low-calorie diet can achieve remission in Chinese T2DM patients.

However, adverse effects during the intervention, such as fatigue, appetite, and constipation, have become significant barriers to successful remission. These symptoms often result in poor adherence to the intervention plan and, consequently, failure to achieve remission. In traditional Chinese medicine (TCM), fatigue and constipation are typical symptoms of "Qi Vacuity", while hunger is more associated with "Yin Vacuity". "Herb is the food" is a unique concept in TCM. Integrating TCM herbs into a low-calorie diet may help alleviate these adverse effects and improve the likelihood of achieving diabetes remission.

This project aims to investigate the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving remission of T2DM among overweight/obese individuals through a randomized controlled trial. The investigators will also explore individual differences in achieving remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating theories from nutrition and TCM dietetics, this project seeks to provide a novel, evidence-based approach to the management of T2DM in Chinese populations.

Conditions

Type 2 Diabetes Mellitus in Obese; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LCD Group

Participants will receive a Low-Calorie Diet (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) meals for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Low-Calorie Diet

Intervention Type: COMBINATION_PRODUCT

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

LCMD Group

Participants will receive a Low-Calorie Medicine Diet (815-835 kcal/day; approximately 43% carbohydrate, 29% protein, and 29% fat) meals product for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.

Group Type: EXPERIMENTAL

Low-Calorie Medicine Diet

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Feng Tao

Director of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Tao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Municipal Hospital of Traditional Chinese Medicine

Locations

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Feng Tao, M.D.

Role: CONTACT

taofeng@shutcm.edu.cn

+86 (021) 56639828

Other Identifiers

SHMHTCM LCDM

Identifier Type: -

Identifier Source: org_study_id