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This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.
The diagnosis criteria of type 2 diabetes mellitus are in accordance to 1999 World Health Organization (WHO) diabetes diagnostic criteria. The diagnosis criteria of dyslipidemia are based on the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese adults (2016, revision edition). The outcomes mainly include HbA1c, fasting blood glucose, postprandial blood glucose, body weight, waist circumference, blood lipid and TCM symptom score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jiangtang Tiaozhi Recipe Group | Experimental | Jiangtang Tiaozhi formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. |
|
| Metformin Group | Active Comparator | 500mg metformin tablet per time, 3 times a day, take it with meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jiangtang Tiaozhi recipe | Drug | The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline HbA1c at 12 weeks | 0 week, 12 weeks | |
| Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks | 0 week, 4 weeks, 8 weeks,12 weeks | |
| Change from Baseline Postprandial Blood Glucose at 12 weeks | 0 week, 12 weeks | |
| Change from Baseline Low Density Lipoprotein at 12 weeks | 0 week, 12 weeks | |
| Change from Baseline Triglyceride at 12 weeks | 0 week, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks | 0 week, 4 weeks, 8 weeks,12 weeks | |
| Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks | 0 week, 4 weeks, 8 weeks,12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks | 0 week, 12 weeks | |
| Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks | 0 week, 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxing Tian, PhD | Contact | +8601088001166 | tina_yai@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiaxing Tian, PhD | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35185579 | Derived | Wu H, Fang X, Jin D, Miao R, Wei J, Zhao T, Dai D, Liao J, Wang J, Lian F, Tian J. Efficacy and Mechanism of the Jiangtang Tiaozhi Recipe in the Management of Type 2 Diabetes and Dyslipidaemia: A Clinical Trial Protocol. Front Pharmacol. 2022 Feb 4;13:827697. doi: 10.3389/fphar.2022.827697. eCollection 2022. |
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| Metformin | Drug | The metformin tablets (500mg) will be administrated. |
|
|
| Change from Baseline Total Cholesterol at 12 weeks | 0 week, 12 weeks |
| Change from Baseline High Density Lipoprotein at 12 weeks | 0 week, 12 weeks |
| Change from Baseline TCM Symptom Score at 12 weeks | 0 week, 12 weeks |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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