Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

Study Overview
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Brief Summary
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With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia

Detailed Description
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Waist circumference, body mass index, triglycerides, glycosylated hemoglobin, blood glucose were evaluated; liver function, kidney function, blood, urine, stool, adverse event recording, evaluation of low blood sugar event log security.

Official Title
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The Study of TCM in Prevention and Promote of Community-based Diabetes

Conditions
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Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM

Intervention / Treatment
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* Drug: Metformin
* Drug: Jiangtangtiaozhi decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent; waistline male ≥ 90cm, female ≥ 80cm; According to the 1999 WHO standards, meet diagnostic criteria for type 2 diabetes onset and untreated patients, after a screening period (diet + exercise therapy 4 weeks) after the fasting plasma glucose ≥ 7.0mmol • L-1, but fasting blood glucose <13.9mmol • L-1, or 2h postprandial blood glucose ≥ 11.1mmol • L-1; and glycated hemoglobin ≥ 7.0%; After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG <5.65mmol / L; TCM for the heat of the gastrointestinal; Age 30-65 years old. Exclusion Criteria: Patients has been used insulin therapy; previously had a continuous period of 3 months or longer treatment of diabetes(including other Chinese and Western medicine, physical therapy, psychological therapy and health food, etc.) ; enrolled within 1 month before the use of blood glucose and lipids drug treatment; Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases; Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons; Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections; Patients with mental illness; Pregnancy, pregnancy or breast-feeding women to prepare; Patients with Chinese medicine allergies; and allergy; Patients with had participated in this study within 1 month have participated or are participating in other clinical studies; In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence; According to the researchers to determine, with the possibility of lower income group or the other into a complex set of diseases or conditions, such as work environment, frequent changes in unstable living environment, the situation could easily lead to lost; Patients taking the dose and type of antihypertensive drugs can not remain stable; Patients taking drugs that affect the quality of the body or health food. Patients with liver, impaired renal function (ALT, AST greater than 2 times the upper limit of normal; serum creatinine greater than the upper limit of normal); Patients are known to lower blood sugar for those who are asymptomatic.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jiangtangtiaozhi decoction<br> | Drug: Jiangtangtiaozhi decoction<br>* 15 grams each time, twice a day, with boiled water<br>* Other names: a decoction make of 8 herbs;|
| Active Comparator: metformin<br> | Drug: Metformin<br>* 250 mg or 500mg three times a day<br>* Other names: Metformin enteric-coated tablets.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waistline |  | 4 weeks | 
| Triglycerides |  | 12 weeks | 
| Liver function |  | 4 weeks | 
| Renal function |  | 4 weeks | 
| Whole blood cell analysis |  | 4 weeks | 
| Urinalysis |  | 12 weeks | 
| Adverse events recorded |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, obesity, hypertriglyceridemia