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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02848053
• Other study ID #: REDUCES-01
• Status: Not yet recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: October 3, 2016
• Start date: August 2016
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Fengmei Lian, PHD
• Phone: 0086-010-88001402
• Email: lfm565[@]sohu.com
• Is FDA regulated: No
• Health authority: State Administration of Traditional Chinese Medicine: China
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance
• Type 2 Diabetes Mellitus

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Hubei College of Traditional Chinese Medicine

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diabetes		0 week	No
Secondary	Number of participants with abnormal body mass index values (in kg/m^2)		0 week	No
Secondary	Number of participants with abnormal Triglycerides values (in mmol/L)		0 week	No
Secondary	Number of participants with abnormal Cholesterol values (in mmol/L)		0 week	No
Secondary	Number of participants with abnormal Low density lipoprotein values (in mmol/L)		0 week	No
Secondary	Number of participants with abnormal High density lipoprotein values (in mmol/L)		0 week	No
Secondary	Number of participants with abnormal Systolic Blood Pressure values (in mmHg)		0 week	No
Secondary	Number of participants with abnormal Diastolic Blood Pressure values (in mmHg)		0 week	No
Secondary	Number of participants with abnormal blood glucose values (in mmol/L)		0 week	No