CClinicalTrials.gg
Status unknownNCT02502344MIIIROPOAGTUpdated Jul 21, 2016

Effect of Medical Interventions in Insulin Resistance on Prevalence of Abnormal Glucose Tolerance

A Phase 4 interventional study of healthy lifestyle and Metformin in Insulin Resistance, sponsored by Beijing Tsinghua Chang Gung Hospital. Status unknown at 1 site in China. Open to participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-07-21.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Insulin Resistance

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Keywords

  • insulin resistance
  • abnormal glucose tolerance
  • DM prevention
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 96 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI > 28kg/m2
  • diagnosis of insulin resistance

Exclusion criteria

Exclusion Criteria:

  • abnormal glucose tolerance
  • function impairment of heart, liver or kidney
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Behavioral: healthy lifestyle · Drug: Metformin

  • No intervention
    clinical observeral group

    subjects in this group will not accept medical interventions

Interventions

  • Behavioralhealthy lifestyle

    food control and intensive exercise to lose weight

  • DrugMetformin

    use metformin to reduce insulin resistance

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What researchers measure

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

    Time frame: two years after the subject joins the research

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Study locations

1 of 1 sites recruiting
  • BEI JING Tsinghua Changguang Hospital
    Beijing, Beijing 102218, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25070616 ↗
  • 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. PubMed 15561905 ↗
  • 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. PubMed 22385956 ↗
  • 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. PubMed 18502303 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02502344
Lead sponsor
Beijing Tsinghua Chang Gung Hospital
Responsible party
Sponsor
First posted
Jul 20, 2015
Start date
Aug 2015
Primary completion
Aug 2018 (estimated)
Last update
Jul 21, 2016

Study contacts

Zi Q Zeng, Doctor
Contact
zzq@btch.edu.cn
0086-010-56118899 ext. 18101127014
Jian Z Xiao, Doctor
Contact
xiaojzh858@sina.com
0086-010-56118899 ext. 13683685711
Jian Z Xiao, Doctor
study director · Beijing Tsinghua Changgeng Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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