Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance (MIIIROPOAGT)
Primary Purpose
Insulin Resistance
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
healthy lifestyle
Metformin
Sponsored by
About this trial
This is an interventional prevention trial for Insulin Resistance focused on measuring insulin resistance, abnormal glucose tolerance, DM prevention
Eligibility Criteria
Inclusion Criteria:
- BMI > 28kg/m2
- diagnosis of insulin resistance
Exclusion Criteria:
- abnormal glucose tolerance
- function impairment of heart, liver or kidney
Sites / Locations
- BEI JING Tsinghua Changguang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
medical intervention group
clinical observeral group
Arm Description
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.
subjects in this group will not accept medical interventions
Outcomes
Primary Outcome Measures
prevalence of abnormal glucose intolerance
OGTT test will be took in these subjects to find out if their glucose tolerance was abnormal
Secondary Outcome Measures
Full Information
NCT ID
NCT02502344
First Posted
July 15, 2015
Last Updated
July 19, 2016
Sponsor
Beijing Tsinghua Chang Gung Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02502344
Brief Title
Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
Acronym
MIIIROPOAGT
Official Title
The Research About the Influence of Medical Interventions in the Period of Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tsinghua Chang Gung Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
insulin resistance, abnormal glucose tolerance, DM prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
medical intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
clinical observeral group
Arm Type
No Intervention
Arm Description
subjects in this group will not accept medical interventions
Intervention Type
Behavioral
Intervention Name(s)
healthy lifestyle
Intervention Description
food control and intensive exercise to lose weight
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
use metformin to reduce insulin resistance
Primary Outcome Measure Information:
Title
prevalence of abnormal glucose intolerance
Description
OGTT test will be took in these subjects to find out if their glucose tolerance was abnormal
Time Frame
two years after the subject joins the research
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI > 28kg/m2
diagnosis of insulin resistance
Exclusion Criteria:
abnormal glucose tolerance
function impairment of heart, liver or kidney
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zi Q Zeng, Doctor
Phone
0086-010-56118899
Ext
18101127014
Email
zzq@btch.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Z Xiao, Doctor
Phone
0086-010-56118899
Ext
13683685711
Email
xiaojzh858@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Z Xiao, Doctor
Organizational Affiliation
Beijing Tsinghua Changgeng Hospital
Official's Role
Study Director
Facility Information:
Facility Name
BEI JING Tsinghua Changguang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102218
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jian Z xiao, doctor
Phone
0086-010-56118899
Ext
13683685711
Email
xiaojzh858@sina.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25070616
Citation
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.
Results Reference
background
PubMed Identifier
15561905
Citation
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.
Results Reference
background
PubMed Identifier
22385956
Citation
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.
Results Reference
background
PubMed Identifier
18502303
Citation
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.
Results Reference
background
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Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
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