Type 2 Diabetes Mellitus in ObeseLCMDNCT06442150
LCMD for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
A study testing Low-Calorie Medicine Diet and Low-Calorie Diet in people with Type 2 Diabetes Mellitus in Obese and Type 2 Diabetes, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese, Type 2 Diabetes
- What is being tested?
- Low-Calorie Medicine Diet and Low-Calorie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200074
About this study
Official title: Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
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.
Read the 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
- Being tested
- Low-Calorie Medicine Diet, Low-Calorie Diet
- Keywords
- Remission of type 2 diabetes, Low Calorie Diet, Medicined Diet, Brain-Gut-Microbiome axis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Calorie Medicine DietCombination 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 DietCombination product
Low-Calorie Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Low-Calorie Medicine Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline to 12, 24 and 52 weeks
Secondary outcomes (9)
Change from baseline in insulin sensitivity as assessed by insulin tolerance test
Insulin sensitivity is evaluated with insulin tolerance tests at the pre-specified time points.
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in beta cell function as assessed by arginine stimulation test
Beta cell function is evaluated with arginine stimulation test at the pre-specified time points.
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in liver fat content and pancreatic fat content as assessed by magnetic resonance imaging
Liver and pancreatic fat will be assessed using magnetic resonance imaging (MRI) or proton magnetic resonance spectroscopy (1H-MRS). Liver fat content will be quantified as the proton density fat fraction (PDFF) in percentage, while pancreatic fat content will be expressed as the percentage of fat signal relative to the total signal in the region of interest (ROI).
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in plasma glucose concentration
Glucose homeostasis parameters will be assessed, including fasting blood glucose (FBG) in mmol/L, postprandial blood glucose (PBG) in mmol/L 2 hours after a standardized meal, glycated hemoglobin (HbA1c) in percentage, and time in range (TIR), which represents the percentage of time that blood glucose levels remain within the target range (3.9-10.0 mmol/L) as assessed using continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG).
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in fasting serum lipid levels, including total cholesterol, LDL-C, HDL-C, and triglycerides
Lipid profile parameters will be assessed, including total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG). All lipid parameters will be measured in mmol/L after at least 8 hours of fasting.
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in brain functional connectivity and activity as assessed by functional magnetic resonance imaging
Brain functional connectivity and activity will be assessed using functional magnetic resonance imaging (fMRI) during resting state and task-based paradigms. Resting-state fMRI will be used to evaluate the intrinsic functional connectivity among brain regions, focusing on networks related to appetite regulation and cognitive control.
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in gut microbiota composition and its metabolites as assessed by 16S rRNA gene sequencing and metabolomics analysis
Gut microbiota composition and its metabolites will be assessed through the analysis of fecal samples. 16S rRNA gene sequencing will be used to evaluate gut microbial diversity and composition, focusing on the relative abundance of key bacterial taxa at the phylum, family, and genus levels. Metabolomic profiles, including short-chain fatty acids (SCFAs), bile acids, and amino acids, will be quantified using gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS).
Measured: Baseline to 12, 24 and 52 weeks
Change from baseline in the quality of life score as assessed by a validated questionnaire (e.g., SF-36, EQ-5D)
Quality of life will be assessed using various validated questionnaires, including the 36-Item Short Form Health Survey (SF-36) for general health status, the EuroQol Five-Dimension (EQ-5D) questionnaire for health-related quality of life, and the Diabetes-Specific Quality of Life (DSQL) questionnaire for diabetes-specific health-related quality of life. The SF-36 and EQ-5D scores range from 0 to 100, with higher scores indicating better health status. The DSQL scores range from 0 to 100, with lower scores indicating better diabetes-specific quality of life.
Measured: Baseline to 12, 24 and 52 weeks
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Safety will include adverse event incidence, changes in routine blood, urine, and stool tests, alanine transaminase, uric acid, etc. Frequency of constipation and dizziness, as well as scores from PAC-SYM, FSS, FCQ-T, and VAS for hunger, will be assessed.
Measured: 12, 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Tao, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Investigators
- Feng Tao, M.D., Principal investigator, Shanghai Municipal Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442150
- Sponsor's protocol ID
- SHMHTCM LCDM
- Acronym
- LCMD
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences
- ClinicalTrials.gov ID
- NCT06442150
- Acronym / sponsor ID
- LCMD / SHMHTCM LCDM
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| LCD Group | Active comparator | Combination Product: Low-Calorie DietParticipants 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. |
| LCMD Group | Experimental | Combination Product: Low-Calorie Medicine DietParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Calorie Medicine DietLow-Calorie Medicine Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity. | Combination product | LCMD Group |
| Low-Calorie DietLow-Calorie Diet meals which are 815-835 kcal/day (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity. | Combination product | LCD Group |
Primary outcome
Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria
Time frame: Baseline 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 weight
Time frame: Baseline to 12, 24 and 52 weeks
Proportion of participants achieving significant weight loss (≥12kg/10kg).
9 secondary outcomes
Change from baseline in insulin sensitivity as assessed by insulin tolerance test
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in beta cell function as assessed by arginine stimulation test
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in liver fat content and pancreatic fat content as assessed by magnetic resonance imaging
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in plasma glucose concentration
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in fasting serum lipid levels, including total cholesterol, LDL-C, HDL-C, and triglycerides
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in brain functional connectivity and activity as assessed by functional magnetic resonance imaging
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in gut microbiota composition and its metabolites as assessed by 16S rRNA gene sequencing and metabolomics analysis
Time frame: Baseline to 12, 24 and 52 weeks
Change from baseline in the quality of life score as assessed by a validated questionnaire (e.g., SF-36, EQ-5D)
Time frame: Baseline to 12, 24 and 52 weeks
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 12, 24 and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Tao, M.D. principal investigator
Shanghai Municipal Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Calorie Medicine Diet and Low-Calorie Diet in people with Type 2 Diabetes Mellitus in Obese and Type 2 Diabetes, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Tao, M.D. (+86 (021) 56639828, taofeng@shutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving diabetes remission as assessed by American Diabetes Association criteria (time frame: Baseline to 24 and 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.