- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02502344
Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance (MIIIROPOAGT)
July 19, 2016 updated by: Beijing Tsinghua Chang Gung Hospital
The Research About the Influence of Medical Interventions in the Period of Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
This research would take medical interventions in subjects of insulin resistance without abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose tolerance in different groups.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The situation of type 2 DM prevention in China is serious.
The commonly accepted natural course of type 2 DM is as follows: obesity, insulin resistance(hyperinsulemia), abnormal glucose tolerance, DM and complications of DM; correspondently, the function status of pancreas islet β cells are: normal, compensatory, decompensatory, impaired and failure.
Post researches have proved that using medical interventions after the period of insulin resistance when the function status of β cells were compensatory, the course could not be reversed.
There were few clinical researches about effects of medical interventions in the period of insulin resistance .
This research would take medical interventions in subjects of insulin resistance without abnormal glucose tolerance, to see if there were different prevalence of abnormal glucose tolerance in different groups.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 102218
- Recruiting
- BEI JING Tsinghua Changguang Hospital
-
Contact:
- jian Z xiao, doctor
- Phone Number: 13683685711 0086-010-56118899
- Email: xiaojzh858@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI > 28kg/m2
- diagnosis of insulin resistance
Exclusion Criteria:
- abnormal glucose tolerance
- function impairment of heart, liver or kidney
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: medical intervention group
subjects in this group will accept healthy lifestyle changes such as food control and intensive exercise for 3 months first.
Then their insulin resistance will be evaluated again .
If their insulin resistance didn't improve, then they will take metformin 0.5g qd to reduce insulin resistance.
If their insulin resistance improved, they will continued healthy lifestyle changes.
|
food control and intensive exercise to lose weight
use metformin to reduce insulin resistance
|
No Intervention: clinical observeral group
subjects in this group will not accept medical interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of abnormal glucose intolerance
Time Frame: two years after the subject joins the research
|
OGTT test will be took in these subjects to find out if their glucose tolerance was abnormal
|
two years after the subject joins the research
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jian Z Xiao, Doctor, Beijing Tsinghua Changgeng Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li G, Zhang P, Wang J, Gregg EW, Yang W, Gong Q, Li H, Li H, Jiang Y, An Y, Shuai Y, Zhang B, Zhang J, Thompson TJ, Gerzoff RB, Roglic G, Hu Y, Bennett PH. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lancet. 2008 May 24;371(9626):1783-9. doi: 10.1016/S0140-6736(08)60766-7.
- Ferrannini E, Mari A. beta-Cell function in type 2 diabetes. Metabolism. 2014 Oct;63(10):1217-27. doi: 10.1016/j.metabol.2014.05.012. Epub 2014 Jun 11.
- Weir GC, Bonner-Weir S. Five stages of evolving beta-cell dysfunction during progression to diabetes. Diabetes. 2004 Dec;53 Suppl 3:S16-21. doi: 10.2337/diabetes.53.suppl_3.s16.
- Samuel VT, Shulman GI. Mechanisms for insulin resistance: common threads and missing links. Cell. 2012 Mar 2;148(5):852-71. doi: 10.1016/j.cell.2012.02.017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
July 15, 2015
First Submitted That Met QC Criteria
July 16, 2015
First Posted (Estimate)
July 20, 2015
Study Record Updates
Last Update Posted (Estimate)
July 21, 2016
Last Update Submitted That Met QC Criteria
July 19, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12015C1023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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