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

NCT02848053 | Unknown DMC

• 1 other identifier: REDUCES-01
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impaired Glucose Tolerance; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Incidence of diabetes

  0 week

Secondary Outcomes (8)

• 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

Study Arms (2)

Tianqi group

used Tianqi Capsule in the REDUCES study

Other: no intervention

Placebo group

used placebo in the REDUCES study

Other: no intervention

Interventions

no intervention OTHER

Placebo group; Tianqi group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

420 cases

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Hubei College of Traditional Chinese Medicine: collaborator

Related 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 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.

  PMID: 24432995 RESULT

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Xiaolin Tong, PHD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Central Study Contacts

Fengmei Lian, PHD

CONTACT

0086-010-88001402; lfm565@sohu.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10