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

NCT06442150 | Not Yet Recruiting

• 1 other identifier: SHMHTCM LCDM
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus in Obese; Type 2 Diabetes

Keywords

Remission of type 2 diabetes; Low Calorie Diet; Medicined Diet; Brain-Gut-Microbiome axis

Outcome Measures

Primary Outcomes (2)

• Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria

  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.

  Baseline to 24 and 52 weeks

• Number of participants achieving significant weight loss, defined as a reduction of at least 12kg from baseline body weight

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

  Baseline to 12, 24 and 52 weeks

Secondary Outcomes (9)

• Change from baseline in insulin sensitivity as assessed by insulin tolerance test

  Baseline to 12, 24 and 52 weeks

• Change from baseline in beta cell function as assessed by arginine stimulation test

  Baseline to 12, 24 and 52 weeks

• Change from baseline in liver fat content and pancreatic fat content as assessed by magnetic resonance imaging

  Baseline to 12, 24 and 52 weeks

• Change from baseline in plasma glucose concentration

  Baseline to 12, 24 and 52 weeks

• Change from baseline in fasting serum lipid levels, including total cholesterol, LDL-C, HDL-C, and triglycerides

  Baseline to 12, 24 and 52 weeks

Study Arms (2)

LCD Group

ACTIVE COMPARATOR

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.

Combination Product: Low-Calorie Diet

LCMD Group

EXPERIMENTAL

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.

Combination Product: Low-Calorie Medicine Diet

Interventions

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.

LCMD Group

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.

LCD Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200074, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Feng Tao, M.D.

  Shanghai Municipal Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Tao, M.D.

CONTACT

+86 (021) 56639828; taofeng@shutcm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the unique nature of the intervention, it is not feasible to mask the participants and investigators in the treatment allocation. However, the outcomes assessor will be blinded to minimize potential bias in data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 4, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)