Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCMNCT01471275
Chinese Medicine Treatment of Obesity With Type 2 Diabetes, Dyslipidemia
A study testing Metformin and Jiangtangtiaozhi decoction in people with Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 8 sites in China.
Trial summary
With metformin for the control, evaluate the safety and efficacy of Jiangtangtiaozhi decoction in treatment of obesity with type 2 diabetes, dyslipidemia Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM
- What is being tested?
- Metformin and Jiangtangtiaozhi decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 8 sitesChina
- Study dates
- Nov 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country.
Lian Fengmei, doctor contact
Qiang Zhou, doctor contact
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Baoding Hospital of TCM
Baoding, Hebei
Li Liping, lilipingm@163.com
Li Liping, professor
- Recruiting
Guang'anmen Hospital of China Academy ofChinese Medical Sciences
Beijing, Beijing Municipality
Zhou Qiang, doctor, 15101016416, 15101016416@126.com
Tong Xianlin, professor
- Recruiting
Affiliated Hospital of Changchun University of TCM
Changchun, Jilin
Piao Chunli, professor, piaochunli981027@yahoo.com.cn
Piao Chunli, professor
- Recruiting
Tianjin Dagang Hospital
Dagang, Tianjin Municipality
Jin Chuan, 58023442@qq.com
Guo Hailong
- Recruiting
Hangzhou Hospital of TCM
Hangzhou, Zhejiang
Hong Yuzhi, professor, hyzhcy@yahoo.cn
Hong Yuzhi, professor
- Recruiting
Tianjin University of Traditional Chinese Medicine, First Affiliated Hospital
Tianjin, Tianjin Municipality
Wu Shentao, professor, 13752262891, wushentao@yahoo.com.cn
Wu Shentao, professor
- Recruiting
Qinghai Provence Hospital of TCM
Xining, Qinghai
Pu Weirong, puweirong123@163.com
Ba Zhuoma, professor
- Recruiting
Yichang City Yiling Hospital
Yichang, Yichang
Yang Xingzhong, clcy0401@163.com
Yang Xingzhong
About this study
Official title: 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
Read the 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.
- Being tested
- Metformin, Jiangtangtiaozhi decoction
- Keywords
- type 2 diabetes, obesity, hypertriglyceridemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Metformin enteric-coated tablets.
250 mg or 500mg three times a day
Jiangtangtiaozhi decoctionDrug
Also called a decoction make of 8 herbs
15 grams each time, twice a day, with boiled water
| Study group | Role | What they receive |
|---|---|---|
| Jiangtangtiaozhi decoction | Experimental | Not described Receives: Drug: Jiangtangtiaozhi decoction |
| metformin | Active comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated hemoglobin
Measured: 12 weeks
Secondary outcomes (7)
Waistline
Measured: 4 weeks
Triglycerides
Measured: 12 weeks
Liver function
Measured: 4 weeks
Renal function
Measured: 4 weeks
Whole blood cell analysis
Measured: 4 weeks
Urinalysis
Measured: 12 weeks
Adverse events recorded
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengmei Lian, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Xiaolin Tong, Study chair, China academy of Chinese medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471275
- Sponsor's protocol ID
- 368
- Status last verified
- Dec 2011
- First submitted
- 14 Nov 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29808092
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of TCM in Prevention and Promote of Community-based Diabetes
- ClinicalTrials.gov ID
- NCT01471275
- Acronym / sponsor ID
- 368
- Keywords
- type 2 diabetes, obesity, hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jiangtangtiaozhi decoction | Experimental | Drug: Jiangtangtiaozhi decoction |
| metformin | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Metformin enteric-coated tablets.250 mg or 500mg three times a day | Drug | metformin |
| Jiangtangtiaozhi decoctionAlso: a decoction make of 8 herbs15 grams each time, twice a day, with boiled water | Drug | Jiangtangtiaozhi decoction |
Primary outcome
Glycosylated hemoglobin
Time frame: 12 weeks
7 secondary outcomes
Waistline
Time frame: 4 weeks
Triglycerides
Time frame: 12 weeks
Liver function
Time frame: 4 weeks
Renal function
Time frame: 4 weeks
Whole blood cell analysis
Time frame: 4 weeks
Urinalysis
Time frame: 12 weeks
Adverse events recorded
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Derived from this study: PubMed 29808092Yu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Fengmei, doctor contact
Qiang Zhou, doctor contact
Xiaolin Tong study chair
China academy of Chinese medical science
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin and Jiangtangtiaozhi decoction in people with Type 2 Diabetes Mellitus ;Obesity,High Triglycerides；TCM, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lian Fengmei, doctor (lfm565@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated hemoglobin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.