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

NCT ID: NCT02848053

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-11-30

Brief 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.

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.

Conditions

Impaired Glucose Tolerance; Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Tianqi group

used Tianqi Capsule in the REDUCES study

no intervention

Intervention Type: OTHER

Placebo group

used placebo in the REDUCES study

no intervention

Intervention Type: OTHER

Interventions

no intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hubei College of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Lian-fengmei

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolin Tong, PHD

Role: STUDY_CHAIR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Central Contacts

Fengmei Lian, PHD

Role: CONTACT

lfm565@sohu.com

0086-010-88001402

References

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.

Reference Type: RESULT

PMID: 24432995 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

This is the original study, the registration study is the follow-up study aimed at Tianqi capsule

View Document

Other Identifiers

REDUCES-01

Identifier Type: -

Identifier Source: org_study_id