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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

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ClinicalTrials.gov Identifier: NCT02848053
Recruitment Status : Unknown
Verified October 2016 by Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Hubei College of Traditional Chinese Medicine
Information provided by (Responsible Party):
Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.


Condition or disease Intervention/treatment
Impaired Glucose Tolerance Type 2 Diabetes Mellitus 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.


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Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Long-term Effect of Tianqi Capsule Interventions to Prevent Diabetes in the REDUCES Study: a 8-year Follow-up Study
Study Start Date : August 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Incidence of diabetes [ Time Frame: 0 week ]

Secondary Outcome Measures :
  1. Number of participants with abnormal body mass index values (in kg/m^2) [ Time Frame: 0 week ]
  2. Number of participants with abnormal Triglycerides values (in mmol/L) [ Time Frame: 0 week ]
  3. Number of participants with abnormal Cholesterol values (in mmol/L) [ Time Frame: 0 week ]
  4. Number of participants with abnormal Low density lipoprotein values (in mmol/L) [ Time Frame: 0 week ]
  5. Number of participants with abnormal High density lipoprotein values (in mmol/L) [ Time Frame: 0 week ]
  6. Number of participants with abnormal Systolic Blood Pressure values (in mmHg) [ Time Frame: 0 week ]
  7. Number of participants with abnormal Diastolic Blood Pressure values (in mmHg) [ Time Frame: 0 week ]
  8. Number of participants with abnormal blood glucose values (in mmol/L) [ Time Frame: 0 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
420 cases
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848053


Contacts
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Contact: Fengmei Lian, PHD 0086-010-88001402 lfm565@sohu.com

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

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
This is the original study, the registration study is the follow-up study aimed at Tianqi capsule

Publications of Results:
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Responsible Party: Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02848053     History of Changes
Other Study ID Numbers: REDUCES-01
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia