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

Insulin Resistance Clinical Trial

— MIIIROPOAGT  

Official title:

The Research About the Influence of Medical Interventions in the Period of Insulin Resistance on Prevalence of Abnormal Glucose Tolerance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02502344
• Other study ID #: 12015C1023
• Status: Recruiting
• Phase: Phase 4
• First received: July 15, 2015
• Last updated: July 19, 2016
• Start date: August 2015

Study information

• Verified date: July 2016
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Zi Q Zeng, Doctor
• Phone: 0086-010-56118899
• Email: zzq[@]btch.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• BMI > 28kg/m2

• diagnosis of insulin resistance

Exclusion Criteria:

• abnormal glucose tolerance

• function impairment of heart, liver or kidney

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Behavioral:
• healthy lifestyle
food control and intensive exercise to lose weight

Drug:
• Metformin
use metformin to reduce insulin resistance

Locations

Country	Name	City	State
China	BEI JING Tsinghua Changguang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Ferrannini E, Mari A. ß-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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No