Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
Primary Purpose
Type 2 Diabetes Mellitus ;Obesity,High Triglycerides;TCM
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metformin
Jiangtangtiaozhi decoction
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus ;Obesity,High Triglycerides;TCM focused on measuring type 2 diabetes, obesity, hypertriglyceridemia
Eligibility Criteria
Inclusion Criteria:
- signed informed consent;
- waistline male ≥ 90cm, female ≥ 80cm;
- 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%;
- After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG <5.65mmol / L;
- TCM for the heat of the gastrointestinal;
- Age 30-65 years old.
Exclusion Criteria:
- 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;
- Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases;
- Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons;
- Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections;
- Patients with mental illness;
- Pregnancy, pregnancy or breast-feeding women to prepare;
- Patients with Chinese medicine allergies; and allergy;
- Patients with had participated in this study within 1 month have participated or are participating in other clinical studies;
- In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence;
- 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;
- Patients taking the dose and type of antihypertensive drugs can not remain stable;
- Patients taking drugs that affect the quality of the body or health food.
- 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);
- Patients are known to lower blood sugar for those who are asymptomatic.
Sites / Locations
- Guang'anmen Hospital of China Academy ofChinese Medical SciencesRecruiting
- Baoding Hospital of TCMRecruiting
- Affiliated Hospital of Changchun University of TCMRecruiting
- Qinghai Provence Hospital of TCMRecruiting
- Tianjin Dagang HospitalRecruiting
- Tianjin University of Traditional Chinese Medicine, First Affiliated HospitalRecruiting
- Yichang City Yiling HospitalRecruiting
- Hangzhou Hospital of TCMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Jiangtangtiaozhi decoction
metformin
Arm Description
Outcomes
Primary Outcome Measures
Glycosylated hemoglobin
Secondary Outcome Measures
Waistline
Triglycerides
Liver function
Renal function
Whole blood cell analysis
Urinalysis
Adverse events recorded
Full Information
NCT ID
NCT01471275
First Posted
November 14, 2011
Last Updated
December 5, 2011
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01471275
Brief Title
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
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus ;Obesity,High Triglycerides;TCM
Keywords
type 2 diabetes, obesity, hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jiangtangtiaozhi decoction
Arm Type
Experimental
Arm Title
metformin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Metformin enteric-coated tablets.
Intervention Description
250 mg or 500mg three times a day
Intervention Type
Drug
Intervention Name(s)
Jiangtangtiaozhi decoction
Other Intervention Name(s)
a decoction make of 8 herbs
Intervention Description
15 grams each time, twice a day, with boiled water
Primary Outcome Measure Information:
Title
Glycosylated hemoglobin
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Waistline
Time Frame
4 weeks
Title
Triglycerides
Time Frame
12 weeks
Title
Liver function
Time Frame
4 weeks
Title
Renal function
Time Frame
4 weeks
Title
Whole blood cell analysis
Time Frame
4 weeks
Title
Urinalysis
Time Frame
12 weeks
Title
Adverse events recorded
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
signed informed consent;
waistline male ≥ 90cm, female ≥ 80cm;
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%;
After a screening period (diet + exercise therapy 4 weeks) after the triglyceride (TG) ≥ 1.7mmol / L, and TG <5.65mmol / L;
TCM for the heat of the gastrointestinal;
Age 30-65 years old.
Exclusion Criteria:
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;
Patients with diabetic complications; or a serious heart, lung, liver, kidney, brain and other serious complications or associated with other primary diseases;
Patients with uncontrolled blood pressure control, the systolic blood pressure ≥ 160mmHg or (and) diastolic blood pressure ≥ 100mmHg persons;
Patients have diabetic ketoacidosis in the last month, diabetic ketoacidosis and severe infections;
Patients with mental illness;
Pregnancy, pregnancy or breast-feeding women to prepare;
Patients with Chinese medicine allergies; and allergy;
Patients with had participated in this study within 1 month have participated or are participating in other clinical studies;
In the past five years, patients with alcohol and / or psychoactive substances, drug abuse and dependence;
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;
Patients taking the dose and type of antihypertensive drugs can not remain stable;
Patients taking drugs that affect the quality of the body or health food.
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);
Patients are known to lower blood sugar for those who are asymptomatic.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lian Fengmei, doctor
Email
lfm565@sohu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Zhou, doctor
Email
15101016416@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolin Tong
Organizational Affiliation
China academy of Chinese medical science
Official's Role
Study Chair
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy ofChinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou Qiang, doctor
Phone
15101016416
Email
15101016416@126.com
First Name & Middle Initial & Last Name & Degree
Tong Xianlin, professor
First Name & Middle Initial & Last Name & Degree
Lian Fengmei, professor
First Name & Middle Initial & Last Name & Degree
Zhou Qiang, doctor
Facility Name
Baoding Hospital of TCM
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Liping
Email
lilipingm@163.com
First Name & Middle Initial & Last Name & Degree
Li Liping, professor
Facility Name
Affiliated Hospital of Changchun University of TCM
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piao Chunli, professor
Email
piaochunli981027@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Piao Chunli, professor
First Name & Middle Initial & Last Name & Degree
Wang Yanyan
Facility Name
Qinghai Provence Hospital of TCM
City
Xining
State/Province
Qinghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pu Weirong
Email
puweirong123@163.com
First Name & Middle Initial & Last Name & Degree
Ba Zhuoma, professor
First Name & Middle Initial & Last Name & Degree
Pu Weirong
Facility Name
Tianjin Dagang Hospital
City
Dagang
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Chuan
Email
58023442@qq.com
First Name & Middle Initial & Last Name & Degree
Guo Hailong
First Name & Middle Initial & Last Name & Degree
Jin Chuan
Facility Name
Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Shentao, professor
Phone
13752262891
Email
wushentao@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Wu Shentao, professor
First Name & Middle Initial & Last Name & Degree
Wang Bin, doctor
Facility Name
Yichang City Yiling Hospital
City
Yichang
State/Province
Yichang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xingzhong
Email
clcy0401@163.com
First Name & Middle Initial & Last Name & Degree
Yang Xingzhong
Facility Name
Hangzhou Hospital of TCM
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Yuzhi, professor
Email
hyzhcy@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Hong Yuzhi, professor
First Name & Middle Initial & Last Name & Degree
Wei Yan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29808092
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.
Results Reference
derived
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Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
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