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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Insulin Resistance

Intervention / Treatment
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* Behavioral: healthy lifestyle
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 28kg/m2 diagnosis of insulin resistance Exclusion Criteria: abnormal glucose tolerance function impairment of heart, liver or kidney

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical intervention group<br>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<br>* food control and intensive exercise to lose weight<br>Drug: Metformin<br>* use metformin to reduce insulin resistance<br>|
| No Intervention: clinical observeral group<br>subjects in this group will not accept medical interventions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin resistance, abnormal glucose tolerance, DM prevention