Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Treatments: Metformin

Criteria

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.