Clinical trial NCT01471275: Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
Official title: The Study of TCM in Prevention and Promote of Community-based Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
Keywords: type 2 diabetes
obesity
hypertriglyceridemia
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-15
Enrollment: 450
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Glycosylated hemoglobin
timeFrame: 12 weeks
Secondary outcomes:
measure: Waistline
timeFrame: 4 weeks
measure: Triglycerides
timeFrame: 12 weeks
measure: Liver function
timeFrame: 4 weeks
measure: Renal function
timeFrame: 4 weeks
measure: Whole blood cell analysis
timeFrame: 4 weeks
measure: Urinalysis
timeFrame: 12 weeks
measure: Adverse events recorded
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy ofChinese Medical Sciences
state: Beijing
city: Baoding
country: China
facility: Baoding Hospital of TCM
state: Hebei
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of TCM
state: Jilin
city: Xining
country: China
facility: Qinghai Provence Hospital of TCM
state: Qinghai
city: Dagang
country: China
facility: Tianjin Dagang Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital
state: Tianjin
city: Yichang
country: China
facility: Yichang City Yiling Hospital
state: Yichang
city: Hangzhou
country: China
facility: Hangzhou Hospital of TCM
state: Zhejiang
Study officials:
affiliation: China academy of Chinese medical science
name: Xiaolin Tong
role: STUDY_CHAIR
References:
citation: Yu X, Xu L, Zhou Q, Wu S, Tian J, Piao C, Guo H, Zhang J, Li L, Wu S, Guo M, Hong Y, Pu W, Zhao X, Liu Y, Pang B, Peng Z, Wang S, Lian F, Tong X. The Efficacy and Safety of the Chinese Herbal Formula, JTTZ, for the Treatment of Type 2 Diabetes with Obesity and Hyperlipidemia: A Multicenter Randomized, Positive-Controlled, Open-Label Clinical Trial. Int J Endocrinol. 2018 Apr 1;2018:9519231. doi: 10.1155/2018/9519231. eCollection 2018.