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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.
Study Protocol Amendments (v3.0) are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMNT diet | Other | Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6, 12, 24 months |
| HbA1C | Blood test to measure glucose control | 3, 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| γ-GGT | γ-glutamyl transferase (γ-GGT) will be assessed for liver function tests | 3, 6, 12, 24 months |
| Body Mass Index (BMI) | Body Mass Index (BMI) will be measured as an anthropometric parameter (kg/m²) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wu Luo | Contact | +86-0731-8461-5293 | luowubio@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Examination Center of Gezhouba central hospital of Sinopharm | Recruiting | Yichang | Hubei | China | ||
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| 3, 6, 12, 24 months |
| Fasting blood glucose | Fasting blood glucose (mmol/L) will be assessed among Glycemic Homeostasis Parameters | 3, 6, 12, 24 months |
| Fasting insulin | Fasting insulin (μIU/mL) will be assessed among Glycemic Homeostasis Parameters | 3, 6, 12, 24 months |
| Blood lipid | triglyceride, total cholesterol, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein-cholesterol (HDL-C) | 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) | 3, 6, 12, 24 months |
| Hepatic steatosis Markers | Fatty liver index (FLI) Hepatic steatosis index (HSI) | 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. | 3, 6, 12, 24 months |
| Metabolomics | Concentration of Key Serum Metabolites Identified by Metabolomics Before and After CMNT Intervention in All Participants | 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 | 3, 6, 12, 24 months |
| Hunan Shanshui physical examination center |
| Recruiting |
| Changsha |
| Hunan |
| China |
| Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center | Recruiting | Changsha | Hunan | China |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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