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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Anticipated): 420

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

420 cases

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tianqi group; used Tianqi Capsule in the REDUCES study	Other: no intervention
Placebo group; used placebo in the REDUCES study	Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of diabetes	0 week

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Hubei College of Traditional Chinese Medicine
• Investigators: Study Chair: Xiaolin Tong, PHD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
• Other Study ID Numbers: REDUCES-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Clinical Study Report
   Information comments: This is the original study, the registration study is the follow-up study aimed at Tianqi capsule