Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine

Study Overview
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Brief Summary
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This study is a retrospective review of participants who visited Department of Endocrinology, Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis months, from January 2015 to December 2020. All the participants should be diagnosed as type 2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese medicine will be evaluated based on the changes of blood glucose, body mass index, blood lipids, and blood pressure.

Detailed Description
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The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and Treatment of Dyslipidaemia in Adults (2016, revision edition).

Official Title
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Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine: a Retrospective Study

Conditions
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Type 2 Diabetes Mellitus in Obese, Dyslipidemia Associated With Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: Chinese herb medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet at least three of the requirements below; 1) Fasting Plasma Glucose > 6.1 mmol/L or 2-hour Postprandial Blood Glucose > 7.8 mmol/L or diagnosed as type 2 diabetes mellitus; 2) Body Mass Index > 25 kg / m2; 3) Total Cholesterol > 5.2 mmol / L; Or Triglyceride > 1.70 mmol / L; Or Low-Density Lipoprotein > 3.12 mmol / L; Or High-Density Lipoprotein < 1.04 mmol/L. 4) Systolic blood pressure > 130 mmHg or Diastolic blood pressure > 85 mmHg or diagnosed as hypertension; Received 6 months of continuous Chinese herbal medicine treatment; During the period of receiving Chinese herbal medicine, the patients continued to take western medicine according to the doctor's advice as before. During the period of receiving Chinese herbal medicine, diet and exercise continued according to the original routine, and the tests would be reviewed in the same institution. Aged 18 to 80 years at the time of their consent; Signed informed consent. Exclusion Criteria: Patients who had serious heart, lung, liver, kidney and brain diseases; serious infectious or hemorrhagic diseases; serious nervous system diseases, mental instability; or could not cooperate with treatment were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br> | Drug: Chinese herb medicine<br>* Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c at 3 months, 6 months |  | 0 month, 3 months, 6 months | 
| Changes from Baseline Fasting Blood Glucose at 3 months, 6 months |  | 0 month, 3 months, 6 months | 
| Changes from Baseline Low Density Lipoprotein at 3 months, 6 months |  | 0 month, 3 months, 6 months | 
| Changes from Baseline Triglyceride at 3 months, 6 months |  | 0 month, 3 months, 6 months | 
| Changes from Baseline Body Mass Index at 3 months, 6 months |  | 0 month, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Postprandial Blood Glucose at 6 months |  | 0 month, 6 months | 
| Changes from Total Cholesterol at 6 months |  | 0 month, 6 months | 
| Changes from High Density Lipoprotein at 6 months |  | 0 month, 6 months | 
| Changes from Systolic Blood Pressure at 6 months |  | 0 month, 6 months | 
| Changes from Diastolic Blood Pressure at 6 months |  | 0 month, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, dyslipidemias, obesity, Chinese herbal medicine, retrospective review