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

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ClinicalTrials.gov Identifier: NCT02502344
Recruitment Status : Unknown
Verified July 2016 by Beijing Tsinghua Chang Gung Hospital.
Recruitment status was:  Recruiting
First Posted : July 20, 2015
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Beijing Tsinghua Chang Gung Hospital

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Behavioral: healthy lifestyle Drug: Metformin Phase 4

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Research About the Influence of Medical Interventions in the Period of Insulin Resistance on Prevalence of Abnormal Glucose Tolerance
Study Start Date : August 2015
Estimated Primary Completion Date : August 2018

Resource links provided by the National Library of Medicine


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

Drug: Metformin
use metformin to reduce insulin resistance

No Intervention: clinical observeral group
subjects in this group will not accept medical interventions



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502344


Contacts
Contact: Zi Q Zeng, Doctor 0086-010-56118899 ext 18101127014 zzq@btch.edu.cn
Contact: Jian Z Xiao, Doctor 0086-010-56118899 ext 13683685711 xiaojzh858@sina.com

Locations
China, Beijing
BEI JING Tsinghua Changguang Hospital Recruiting
Beijing, Beijing, China, 102218
Contact: jian Z xiao, doctor    0086-010-56118899 ext 13683685711    xiaojzh858@sina.com   
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
Investigators
Study Director: Jian Z Xiao, Doctor Beijing Tsinghua Changgung Hospital