Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
Conditions
Keywords
type 2 diabetes, obesity, hypertriglyceridemia
Brief summary
With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia
Detailed description
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.
Interventions
DRUGMetformin
250 mg or 500mg three times a day
DRUGJiangtangtiaozhi decoction
15 grams each time, twice a day, with boiled water
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides | 12 weeks |
| Liver function | 4 weeks |
| Renal function | 4 weeks |
| Waistline | 4 weeks |
| Urinalysis | 12 weeks |
| Adverse events recorded | 4 weeks |
| Whole blood cell analysis | 4 weeks |
Countries
China
Contacts
Primary ContactLian Fengmei, doctor
Backup ContactQiang Zhou, doctor
Outcome results
None listed