Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

Not Applicable

• Conditions: Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
• Interventions: Drug: Jiangtangtiaozhi decoction; Drug: Metformin

• Registration Number: NCT01471275
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-15
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06
• Primary Completion: 2013-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jiangtangtiaozhi decoction	Jiangtangtiaozhi decoction	-
metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Qinghai Provence Hospital of TCM; 🇨🇳 Xining, Qinghai, China

Guang'anmen Hospital of China Academy ofChinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Baoding Hospital of TCM; 🇨🇳 Baoding, Hebei, China

Affiliated Hospital of Changchun University of TCM; 🇨🇳 Changchun, Jilin, China

Tianjin Dagang Hospital; 🇨🇳 Dagang, Tianjin, China

Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital; 🇨🇳 Tianjin, Tianjin, China

Yichang City Yiling Hospital; 🇨🇳 Yichang, Yichang, China

Hangzhou Hospital of TCM; 🇨🇳 Hangzhou, Zhejiang, China