Impaired Glucose ToleranceNCT02848053
The Long-term Effect of Tianqi Capsule Interventions to Prevent Diabetes in the REDUCES Study: a 8-year Follow-up Study
An observational study of Impaired Glucose Tolerance and Type 2 Diabetes Mellitus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a long-term effect on the risk of diabetes and provide evidence that early intervention by traditional Chinese medicine could delay the progression from impaired glucose tolerance to diabetes. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Impaired Glucose Tolerance, Type 2 Diabetes Mellitus
- Type of treatment
- Pill or oral medicine
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Nov 2016
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 420 cases
Who may be able to join
- Subjects have participated in the REDUCES study before;
- Informed consent forms were needed to participants performed to blood test;
- Laboratory sheets could be voluntary acquirement by participants that determined the status of glucose metabolism;
- Subjects were not disabled, and could take care of themselves. 5. Subjects did not suffer the infectious disease.
Who cannot join
- Subjects did not participate the REDUCES study;
- Subjects suffered serious mental illness;
- Subjects suffered severe mental or cognitive impairment;
- Subjects had a history of drug or alcohol dependence;
- Subjects have participated in other drug clinical trials in the past 1 month.
Trial locations and contacts
No sites are listed yet.
About this study
Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a long-term effect on the risk of diabetes and provide evidence that early intervention by traditional Chinese medicine could delay the progression from impaired glucose tolerance to diabetes.
Study contents: 1.420 participants were followed up for 8 years to assess the long-term effect of Tianqi Capsule. Phone-call followed up was applied to investigate the status of impaired glucose tolerance and orthoglycemic survivors until the end of REDUCES study. 2.To participants that determined the status of glucose metabolism, a variety of ways were used to find the evidence of diagnosis of glucose metabolic status, such as glycemia laboratory sheets from normal hospitals, medical records, the use of antidiabetic drugs or insulin injection, etc. 3. To participants that undiagnosed the status of glucose metabolism, oral glucose tolerance test, blood pressure, weight and blood biochemical analysis were performed to assess the state of glucose metabolism. 4. Questionnaires were given to all the participants to investigate their condition of treatment, diet, exercise and other lifestyle.
Read the detailed description
Study design: Perspective study Study drug: Tianqi CapsuleInclusion criteria: 1. Subjects have participated in the REDUCES study before; 2. Informed consent forms were needed to participants performed to blood test; 3. Laboratory sheets could be voluntary acquirement by participants that determined the status of glucose metabolism; 4.Subjects were not disabled, and could take care of themselves. 5. Subjects did not suffer the infectious disease.
Exclusion criteria: 1. Subjects did not participate the REDUCES study; 2. Subjects suffered serious mental illness; 3. Subjects suffered severe mental or cognitive impairment; 4. Subjects had a history of drug or alcohol dependence; 5. Subjects have participated in other drug clinical trials in the past 1 month.
Main outcome index: Incidence of diabetes. Secondary outcome index: Body mass index, fasting blood-glucose, postprandial blood sugar, blood lipids, blood pressure.
- Being tested
- no intervention
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Tianqi group | used Tianqi Capsule in the REDUCES study Receives: Other: no intervention | |
| Placebo group | used placebo in the REDUCES study Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of diabetes
Measured: 0 week
Secondary outcomes (8)
Number of participants with abnormal body mass index values (in kg/m^2)
Measured: 0 week
Number of participants with abnormal Triglycerides values (in mmol/L)
Measured: 0 week
Number of participants with abnormal Cholesterol values (in mmol/L)
Measured: 0 week
Number of participants with abnormal Low density lipoprotein values (in mmol/L)
Measured: 0 week
Number of participants with abnormal High density lipoprotein values (in mmol/L)
Measured: 0 week
Number of participants with abnormal Systolic Blood Pressure values (in mmHg)
Measured: 0 week
Number of participants with abnormal Diastolic Blood Pressure values (in mmHg)
Measured: 0 week
Number of participants with abnormal blood glucose values (in mmol/L)
Measured: 0 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (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 Impaired Glucose ToleranceStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei College of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Xiaolin Tong, PHD, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848053
- Sponsor's protocol ID
- REDUCES-01
- Status last verified
- Oct 2016
- First submitted
- 21 Jul 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lian F, Li G, Chen X, Wang X, Piao C, Wang J, Hong Y, Ba Z, Wu S, Zhou X, Lang J, Liu Y, Zhang R, Hao J, Zhu Z, Li H, Fang Liu H, Cao A, Yan Z, An Y, Bai Y, Wang Q, Zhen Z, Yu C, Wang CZ, Yuan CS, Tong X. Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial. J Clin Endocrinol Metab. 2014 Feb;99(2):648-55. doi: 10.1210/jc.2013-3276. Epub 2014 Jan 16.
PubMed 24432995
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect of Tianqi Capsule Interventions to Prevent Diabetes in the REDUCES Study: a 8-year Follow-up Study
- ClinicalTrials.gov ID
- NCT02848053
- Acronym / sponsor ID
- REDUCES-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Hubei College of Traditional Chinese Medicine
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 28 Jul 2016 (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.
Objectives: This study is aimed to assess whether Tianqi Capsule interventions have a long-term effect on the risk of diabetes and provide evidence that early intervention by traditional Chinese medicine could delay the progression from impaired glucose tolerance to diabetes.
Study contents: 1.420 participants were followed up for 8 years to assess the long-term effect of Tianqi Capsule. Phone-call followed up was applied to investigate the status of impaired glucose tolerance and orthoglycemic survivors until the end of REDUCES study. 2.To participants that determined the status of glucose metabolism, a variety of ways were used to find the evidence of diagnosis of glucose metabolic status, such as glycemia laboratory sheets from normal hospitals, medical records, the use of antidiabetic drugs or insulin injection, etc. 3. To participants that undiagnosed the status of glucose metabolism, oral glucose tolerance test, blood pressure, weight and blood biochemical analysis were performed to assess the state of glucose metabolism. 4. Questionnaires were given to all the participants to investigate their condition of treatment, diet, exercise and other lifestyle.
Detailed description
Study design: Perspective study Study drug: Tianqi CapsuleInclusion criteria: 1. Subjects have participated in the REDUCES study before; 2. Informed consent forms were needed to participants performed to blood test; 3. Laboratory sheets could be voluntary acquirement by participants that determined the status of glucose metabolism; 4.Subjects were not disabled, and could take care of themselves. 5. Subjects did not suffer the infectious disease.
Exclusion criteria: 1. Subjects did not participate the REDUCES study; 2. Subjects suffered serious mental illness; 3. Subjects suffered severe mental or cognitive impairment; 4. Subjects had a history of drug or alcohol dependence; 5. Subjects have participated in other drug clinical trials in the past 1 month.
Main outcome index: Incidence of diabetes. Secondary outcome index: Body mass index, fasting blood-glucose, postprandial blood sugar, blood lipids, blood pressure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tianqi group | – | Other: no interventionused Tianqi Capsule in the REDUCES study |
| Placebo group | – | Other: no interventionused placebo in the REDUCES study |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 420 cases
Key inclusion criteria (4 listed)
- Subjects have participated in the REDUCES study before;
- Informed consent forms were needed to participants performed to blood test;
- Laboratory sheets could be voluntary acquirement by participants that determined the status of glucose metabolism;
- Subjects were not disabled, and could take care of themselves. 5. Subjects did not suffer the infectious disease.
Key exclusion criteria (5 listed)
- Subjects did not participate the REDUCES study;
- Subjects suffered serious mental illness;
- Subjects suffered severe mental or cognitive impairment;
- Subjects had a history of drug or alcohol dependence;
- Subjects have participated in other drug clinical trials in the past 1 month.
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 |
|---|---|---|
| no intervention | Other | Placebo group, Tianqi group |
Primary outcome
Incidence of diabetes
Time frame: 0 week
8 secondary outcomes
Number of participants with abnormal body mass index values (in kg/m^2)
Time frame: 0 week
Number of participants with abnormal Triglycerides values (in mmol/L)
Time frame: 0 week
Number of participants with abnormal Cholesterol values (in mmol/L)
Time frame: 0 week
Number of participants with abnormal Low density lipoprotein values (in mmol/L)
Time frame: 0 week
Number of participants with abnormal High density lipoprotein values (in mmol/L)
Time frame: 0 week
Number of participants with abnormal Systolic Blood Pressure values (in mmHg)
Time frame: 0 week
Number of participants with abnormal Diastolic Blood Pressure values (in mmHg)
Time frame: 0 week
Number of participants with abnormal blood glucose values (in mmol/L)
Time frame: 0 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Results publication: PubMed 24432995Lian F, Li G, Chen X, Wang X, Piao C, Wang J, Hong Y, Ba Z, Wu S, Zhou X, Lang J, Liu Y, Zhang R, Hao J, Zhu Z, Li H, Fang Liu H, Cao A, Yan Z, An Y, Bai Y, Wang Q, Zhen Z, Yu C, Wang CZ, Yuan CS, Tong X. Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial. J Clin Endocrinol Metab. 2014 Feb;99(2):648-55. doi: 10.1210/jc.2013-3276. Epub 2014 Jan 16.
- Individual participant dataSharing planned: Undecided
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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.
Xiaolin Tong, PHD study chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Glucose Tolerance and Type 2 Diabetes Mellitus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 4 inclusion and 5 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Fengmei Lian, PHD (0086-010-88001402, lfm565@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diabetes (time frame: 0 week). 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 NCT02848053, 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 4 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.