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

Beijing Tsinghua Chang Gung Hospital

Status and phase: Unknown; Phase 4

Conditions: Insulin Resistance

Treatments: Behavioral: healthy lifestyle; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02502344

12015C1023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

medical intervention group

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Behavioral: healthy lifestyle

clinical observeral group

No Intervention group

Description:

subjects in this group will not accept medical interventions