Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
MIIIROPOAGT
The Research About the Influence of Medical Interventions in the Period of Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedJuly 21, 2016
July 1, 2016
3 years
July 15, 2015
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prevalence of abnormal glucose intolerance
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
Study Arms (2)
medical intervention group
EXPERIMENTALsubjects 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.
clinical observeral group
NO INTERVENTIONsubjects in this group will not accept medical interventions
Interventions
food control and intensive exercise to lose weight
Eligibility Criteria
You may qualify if:
- BMI \> 28kg/m2
- diagnosis of insulin resistance
You may not qualify if:
- abnormal glucose tolerance
- function impairment of heart, liver or kidney
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BEI JING Tsinghua Changguang Hospital
Beijing, Beijing Municipality, 102218, China
Related Publications (4)
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.
PMID: 25070616BACKGROUNDWeir 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.
PMID: 15561905BACKGROUNDSamuel 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.
PMID: 22385956BACKGROUNDLi 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.
PMID: 18502303BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jian Z Xiao, Doctor
Beijing Tsinghua Changgeng Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 20, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2018
Last Updated
July 21, 2016
Record last verified: 2016-07