Type 2 Diabetes Mellitus ;Obesity,High Triglycerides;TCM Clinical Trial
Official title:
The Study of TCM in Prevention and Promote of Community-based Diabetes
With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia
| Status | Recruiting |
| Enrollment | 450 |
| Est. completion date | December 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. signed informed consent; 2. waistline male = 90cm, female = 80cm; 3. 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%; 4. After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) = 1.7mmol / L, and TG <5.65mmol / L; 5. TCM for the heat of the gastrointestinal; 6. Age 30-65 years old. Exclusion Criteria: 1. 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; 2. Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases; 3. Patients with uncontrolled blood pressure control, the systolic blood pressure = 160mmHg or (and) diastolic blood pressure = 100mmHg persons; 4. Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections; 5. Patients with mental illness; 6. Pregnancy, pregnancy or breast-feeding women to prepare; 7. Patients with Chinese medicine allergies; and allergy; 8. Patients with had participated in this study within 1 month have participated or are participating in other clinical studies; 9. In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence; 10. 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; 11. Patients taking the dose and type of antihypertensive drugs can not remain stable; 12. Patients taking drugs that affect the quality of the body or health food. 13. 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); 14. Patients are known to lower blood sugar for those who are asymptomatic. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Baoding Hospital of TCM | Baoding | Hebei |
| China | Guang'anmen Hospital of China Academy ofChinese Medical Sciences | Beijing | Beijing |
| China | Affiliated Hospital of Changchun University of TCM | Changchun | Jilin |
| China | Tianjin Dagang Hospital | Dagang | Tianjin |
| China | Hangzhou Hospital of TCM | Hangzhou | Zhejiang |
| China | Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital | Tianjin | Tianjin |
| China | Qinghai Provence Hospital of TCM | Xining | Qinghai |
| China | Yichang City Yiling Hospital | Yichang | Yichang |
| Lead Sponsor | Collaborator |
|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glycosylated hemoglobin | 12 weeks | No | |
| Secondary | Waistline | 4 weeks | No | |
| Secondary | Triglycerides | 12 weeks | No | |
| Secondary | Liver function | 4 weeks | Yes | |
| Secondary | Renal function | 4 weeks | Yes | |
| Secondary | Whole blood cell analysis | 4 weeks | Yes | |
| Secondary | Urinalysis | 12 weeks | Yes | |
| Secondary | Adverse events recorded | 4 weeks | Yes |