Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia

December 5, 2011 updated by: Fengmei Lian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

The Study of TCM in Prevention and Promote of Community-based Diabetes

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Guang'anmen Hospital of China Academy ofChinese Medical Sciences
        • Contact:
        • Principal Investigator:
          • Tong Xianlin, professor
        • Sub-Investigator:
          • Lian Fengmei, professor
        • Sub-Investigator:
          • Zhou Qiang, doctor
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • Baoding Hospital of TCM
        • Contact:
        • Principal Investigator:
          • Li Liping, professor
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Affiliated Hospital of Changchun University of TCM
        • Contact:
        • Principal Investigator:
          • Piao Chunli, professor
        • Sub-Investigator:
          • Wang Yanyan
    • Qinghai
      • Xining, Qinghai, China
        • Recruiting
        • Qinghai Provence Hospital of TCM
        • Contact:
        • Principal Investigator:
          • Ba Zhuoma, professor
        • Sub-Investigator:
          • Pu Weirong
    • Tianjin
      • Dagang, Tianjin, China
        • Recruiting
        • Tianjin Dagang Hospital
        • Contact:
        • Principal Investigator:
          • Guo Hailong
        • Sub-Investigator:
          • Jin Chuan
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Wu Shentao, professor
        • Sub-Investigator:
          • Wang Bin, doctor
    • Yichang
      • Yichang, Yichang, China
        • Recruiting
        • Yichang City Yiling Hospital
        • Contact:
        • Principal Investigator:
          • Yang Xingzhong
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou Hospital of TCM
        • Contact:
        • Principal Investigator:
          • Hong Yuzhi, professor
        • Sub-Investigator:
          • Wei Yan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metformin
Drug: Metformin
250 mg or 500mg three times a day
Other Names:
  • Metformin enteric-coated tablets.
Experimental: Jiangtangtiaozhi decoction
Drug: Jiangtangtiaozhi decoction
15 grams each time, twice a day, with boiled water
Other Names:
  • a decoction make of 8 herbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycosylated hemoglobin
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Triglycerides
Time Frame: 12 weeks
12 weeks
Urinalysis
Time Frame: 12 weeks
12 weeks
Waistline
Time Frame: 4 weeks
4 weeks
Liver function
Time Frame: 4 weeks
4 weeks
Renal function
Time Frame: 4 weeks
4 weeks
Whole blood cell analysis
Time Frame: 4 weeks
4 weeks
Adverse events recorded
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Xiaolin Tong, China academy of Chinese medical science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 5, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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