The Long-term Effect of Tianqi Capsule Interventions to Prevent Diabetes in the REDUCES Study: a 8-year Follow-up Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Long-term Effect of Tianqi Capsule Interventions to Prevent Diabetes in the REDUCES Study: a 8-year Follow-up Study

Conditions
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Impaired Glucose Tolerance, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tianqi group<br>used Tianqi Capsule in the REDUCES study | Other: no intervention<br> <br> |
| Placebo group<br>used placebo in the REDUCES study | Other: no intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of diabetes |  | 0 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with abnormal body mass index values (in kg/m^2) |  | 0 week | 
| Number of participants with abnormal Triglycerides values (in mmol/L) |  | 0 week | 
| Number of participants with abnormal Cholesterol values (in mmol/L) |  | 0 week | 
| Number of participants with abnormal Low density lipoprotein values (in mmol/L) |  | 0 week | 
| Number of participants with abnormal High density lipoprotein values (in mmol/L) |  | 0 week | 
| Number of participants with abnormal Systolic Blood Pressure values (in mmHg) |  | 0 week | 
| Number of participants with abnormal Diastolic Blood Pressure values (in mmHg) |  | 0 week | 
| Number of participants with abnormal blood glucose values (in mmol/L) |  | 0 week |