Type 2 Diabetes MellitusNCT07083336
Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease (Version 3.0)
A study testing CMNT diet in people with Type 2 Diabetes Mellitus and Metabolic Dysfunction-associated Steatotic Liver Disease, run by State Key Laboratory of Subhealth Intervention Technology at 3 sites in China.
Trial summary
This study aims to explore the efficacy of CMNT, an intermittent energy restriction (iER) intervention, in managing Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Metabolic Dysfunction-associated Steatotic Liver Disease
- What is being tested?
- CMNT diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 5 Jun 2022to 5 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes and NAFLD.
- Age between 18 and 75 years.
- Body mass index (BMI) > 18.0 kg/m2
- Weight stable for at least 3 months prior to the study (gain or loss <4kg).
- Stable treatment for at least 3 months with 1-3 oral
- antidiabetic medications (with or without insulin therapy), or not yet receiving antidiabetic medication prior to the beginning of the study.
- Able to give written informed consent.
Who cannot join
- Participants meeting any of the following criteria will not be allowed to participate in the trial:
- Use of any of the following medications or treatments:
- Use of other medications that may affect glucose metabolism within the past 2 months, including systemic glucocorticoids (excluding inhaled or topical use), growth hormones, etc.;
- Use of antihypertensive or lipid-lowering medications that have not reached a stable dosage before screening;
- Presence of any of the following medical histories or conditions:
- History or presence of any cardiac disease within the past 6 months;
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- Decompensated heart failure (NYHA Class III or IV);
- Unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stenting;
- Uncontrolled or severe arrhythmias (e.g., long QT syndrome), as assessed by the investigator as unsuitable for trial participation;
- History of hemorrhagic or ischemic stroke within the past 6 months, as assessed by the investigator as unsuitable for trial participation;
- Medical history of cerebral thrombosis, cerebral vascular blockage, encephalic angioma, transient ischemic attack, cerebral hemorrhage, stroke, hydrocephalus, or malignant brain tumor;
- History of carotid artery stenting;
- Urinary system conditions such as nephrotic syndrome, uremia, polycystic kidney disease, kidney transplantation, unilateral nephrectomy/congenital solitary kidney, renal atrophy, renal tumor;
- Digestive system conditions such as ascites, liver cirrhosis, liver fluke infection, severe hepatitis, gastric varices;
- Nervous system conditions such as cerebellar atrophy, demyelinating diseases, cerebral palsy, Parkinson's disease, mania, schizophrenia;
- Respiratory system conditions such as pulmonary embolism, cor pulmonale;
- Musculoskeletal system conditions such as arterial rupture, myeloma;
- Immune system conditions such as Behçet's disease, lupus erythematosus;
- Conditions such as chondrosarcoma, liposarcoma, brucellosis, leukemia;
- History of malignant tumor within the past 5 years, or currently under evaluation for potential malignancy;
- History of unstable or treatment-requiring proliferative retinopathy or macular edema within the past 6 months;
- History of diabetic ketoacidosis or hyperosmolar nonketotic diabetic coma within the past 6 months;
- Currently suffering from lower extremity arteriosclerotic occlusive disease; History of severe infection or severe trauma within the past 1 month;
- History of ≥2 severe hypoglycemic episodes within the past year;
- Currently suffering from clinically significant urinary tract/genital infection, or a history of complicated urinary tract infections, or recurrent urinary tract infections within the past 6 months;
- Currently suffering from uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening/baseline, or systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤60 mmHg;
- Currently suffering from uncontrolled thyroid dysfunction;
- History of other severe endocrine diseases, such as multiple endocrine neoplasia;
- History of severe hepatic or renal disease;
- Suspected or confirmed history of alcohol or drug abuse;
- Blood donation or blood loss ≥400 mL within the past 3 months;
- Presence of severe psychiatric disorders or language barriers, unwillingness or inability to fully understand and cooperate;
- Pregnant or breastfeeding women;
- Any other conditions deemed unsuitable for trial participation by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hunan Shanshui physical examination center
Changsha, Hunan
- Recruiting
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, Hunan
- Recruiting
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, Hubei
About this study
Official title: Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
This study aims to explore the efficacy of CMNT, an intermittent energy restriction (iER) intervention, in managing Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease. An interim analysis will be added to the planned 120-participant CMNT intervention program to compare intervention efficacy with the usual care control group and assess potential risks associated with dietary interventions.
Read the detailed description
Study Protocol Amendments (v3.0) are as follows:
- Addition of Interim Analysis. Rationale: The purpose of adding an interim analysis is to evaluate the effectiveness of the CMNT dietary intervention during this clinical trial, while also assessing participant compliance and the safety of the energy-restricted diet.
- Expansion of BMI Inclusion Criteria. The BMI inclusion criterion was revised from "18-35" to " > 18" (removing the upper limit) to include patients with higher BMI values. Rationale: In clinical practice, some patients with a BMI over 35 have shown interest in participating in this study. After evaluation by physicians, these patients can be included.
- Increase in the Number of Multicenter Sites. The number of centers increased from 3 to 6. Rationale: Expanding the number of multicenter sites accelerates participant recruitment. Given the study's focus on patients with T2D and NAFLD, the recruitment of patients with comorbidities is relatively challenging. Additionally, expanding the number of centers enhances the generalizability of the study's conclusions, making them applicable to patients in more regions.
- Clarification and Revision of Secondary Objectives and Corresponding Evaluation Criteria. Addition of metabolomics content to identify key metabolites in CMNT intervention; Screening for key microbial taxa post - CMNT intervention based on gut microbiota results; Validation of the causal relationship between diet and gut microbiota using fecal transplantation; Rationale: Incorporating gut microbiota and metabolomics indicators helps better explore the mechanism of CMNT dietary intervention in this population.
- The participant recruitment period has been extended to May 5, 2026. Rationale: Due to the severe COVID-19 pandemic during 2022-2023, coupled with the fact that this study focuses on comorbidities, the number of eligible participants has been significantly lower compared to studies involving general T2D patients. Furthermore, as most individuals currently do not prioritize fatty liver screening, participant recruitment has progressed more slowly than anticipated. Therefore, an extension of the recruitment period is necessary.
- Being tested
- CMNT diet
- Keywords
- Comorbid MASLD and T2DM, Intermittent energy restriction
- 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.
CMNT dietOther
Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CMNT diet | Experimental | The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle Receives: Other: CMNT diet |
| Usual Care | No intervention | Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled attenuation parameter (CAP) value by transient elastography
The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP < 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP > 291 dB/m denoted severe steatosis.
Measured: 3, 6, 12, 24 months
HbA1C
Blood test to measure glucose control
Measured: 3, 6, 12, 24 months
Secondary outcomes (10)
γ-GGT
γ-glutamyl transferase (γ-GGT) will be assessed for liver function tests
Measured: 3, 6, 12, 24 months
Body Mass Index (BMI)
Body Mass Index (BMI) will be measured as an anthropometric parameter (kg/m²)
Measured: 3, 6, 12, 24 months
Fasting blood glucose
Fasting blood glucose (mmol/L) will be assessed among Glycemic Homeostasis Parameters
Measured: 3, 6, 12, 24 months
Fasting insulin
Fasting insulin (μIU/mL) will be assessed among Glycemic Homeostasis Parameters
Measured: 3, 6, 12, 24 months
Blood lipid
triglyceride, total cholesterol, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein-cholesterol (HDL-C)
Measured: 3, 6, 12, 24 months
Liver fibrosis markers
Liver stiffness measurement (LSM) value by transient elastography DiabetesLiver score Fibrotic non-alcoholic steatohepatitis index (FNI) Fibrosis-4 index (FIB-4) NAFLD fibrosis score (NFS)
Measured: 3, 6, 12, 24 months
Hepatic steatosis Markers
Fatty liver index (FLI) Hepatic steatosis index (HSI)
Measured: 3, 6, 12, 24 months
Food Frequency Questionnaire (FFQ)
The Food Frequency Questionnaire (FFQ) typically estimates nutrient intake based on food consumption frequency, with a common range of 800-5000 kcal/day for adults.
Measured: 3, 6, 12, 24 months
Metabolomics
Concentration of Key Serum Metabolites Identified by Metabolomics Before and After CMNT Intervention in All Participants
Measured: 3, 6, 12, 24 months
Gut microbiota
Change in Gut Microbiota Composition (Relative Abundance at species Level) Before and After CMNT Intervention in All Participants
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start5 Jun 2022
- Primary completion5 May 2026 (estimated)
- Study completion5 Jun 2026 (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 MellitusStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Key Laboratory of Subhealth Intervention Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083336
- Sponsor's protocol ID
- Version 3.0
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07083336
- Acronym / sponsor ID
- Version 3.0
- Keywords
- Comorbid MASLD and T2DM, Intermittent energy restriction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- State Key Laboratory of Subhealth Intervention TechnologyUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
This study aims to explore the efficacy of CMNT, an intermittent energy restriction (iER) intervention, in managing Chinese adults with type 2 diabetes and non-alcoholic fatty liver disease. An interim analysis will be added to the planned 120-participant CMNT intervention program to compare intervention efficacy with the usual care control group and assess potential risks associated with dietary interventions.
Detailed description
Study Protocol Amendments (v3.0) are as follows:
- Addition of Interim Analysis. Rationale: The purpose of adding an interim analysis is to evaluate the effectiveness of the CMNT dietary intervention during this clinical trial, while also assessing participant compliance and the safety of the energy-restricted diet.
- Expansion of BMI Inclusion Criteria. The BMI inclusion criterion was revised from "18-35" to " > 18" (removing the upper limit) to include patients with higher BMI values. Rationale: In clinical practice, some patients with a BMI over 35 have shown interest in participating in this study. After evaluation by physicians, these patients can be included.
- Increase in the Number of Multicenter Sites. The number of centers increased from 3 to 6. Rationale: Expanding the number of multicenter sites accelerates participant recruitment. Given the study's focus on patients with T2D and NAFLD, the recruitment of patients with comorbidities is relatively challenging. Additionally, expanding the number of centers enhances the generalizability of the study's conclusions, making them applicable to patients in more regions.
- Clarification and Revision of Secondary Objectives and Corresponding Evaluation Criteria. Addition of metabolomics content to identify key metabolites in CMNT intervention; Screening for key microbial taxa post - CMNT intervention based on gut microbiota results; Validation of the causal relationship between diet and gut microbiota using fecal transplantation; Rationale: Incorporating gut microbiota and metabolomics indicators helps better explore the mechanism of CMNT dietary intervention in this population.
- The participant recruitment period has been extended to May 5, 2026. Rationale: Due to the severe COVID-19 pandemic during 2022-2023, coupled with the fact that this study focuses on comorbidities, the number of eligible participants has been significantly lower compared to studies involving general T2D patients. Furthermore, as most individuals currently do not prioritize fatty liver screening, participant recruitment has progressed more slowly than anticipated. Therefore, an extension of the recruitment period is necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: CMNT diet | Experimental | Other: CMNT dietThe CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle |
| Usual Care | No intervention | –Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed with type 2 diabetes and NAFLD.
- Age between 18 and 75 years.
- Body mass index (BMI) > 18.0 kg/m2
- Weight stable for at least 3 months prior to the study (gain or loss <4kg).
- Stable treatment for at least 3 months with 1-3 oral
Key exclusion criteria (34 listed)
- Participants meeting any of the following criteria will not be allowed to participate in the trial:
- Use of any of the following medications or treatments:
- Use of other medications that may affect glucose metabolism within the past 2 months, including systemic glucocorticoids (excluding inhaled or topical use), growth hormones, etc.;
- Use of antihypertensive or lipid-lowering medications that have not reached a stable dosage before screening;
- Presence of any of the following medical histories or conditions:
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 |
|---|---|---|
| CMNT dietHypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet | Other | Experimental: CMNT diet |
Primary outcome
Controlled attenuation parameter (CAP) value by transient elastography
Time frame: 3, 6, 12, 24 months
The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP < 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP > 291 dB/m denoted severe steatosis.
HbA1C
Time frame: 3, 6, 12, 24 months
Blood test to measure glucose control
10 secondary outcomes
γ-GGT
Time frame: 3, 6, 12, 24 months
Body Mass Index (BMI)
Time frame: 3, 6, 12, 24 months
Fasting blood glucose
Time frame: 3, 6, 12, 24 months
Fasting insulin
Time frame: 3, 6, 12, 24 months
Blood lipid
Time frame: 3, 6, 12, 24 months
Liver fibrosis markers
Time frame: 3, 6, 12, 24 months
Hepatic steatosis Markers
Time frame: 3, 6, 12, 24 months
Food Frequency Questionnaire (FFQ)
Time frame: 3, 6, 12, 24 months
Metabolomics
Time frame: 3, 6, 12, 24 months
Gut microbiota
Time frame: 3, 6, 12, 24 months
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 24 Jul 2025.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMNT diet in people with Type 2 Diabetes Mellitus and Metabolic Dysfunction-associated Steatotic Liver Disease, run by State Key Laboratory of Subhealth Intervention Technology at 3 sites 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 7 inclusion and 34 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Wu Luo (+86-0731-8461-5293, luowubio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlled attenuation parameter (CAP) value by transient elastography (time frame: 3, 6, 12, 24 months). 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 24 Jul 2025.