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

NCT ID: NCT02502344

Last Updated: 2016-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

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.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

healthy lifestyle

Intervention Type BEHAVIORAL

food control and intensive exercise to lose weight

Metformin

Intervention Type DRUG

use metformin to reduce insulin resistance

clinical observeral group

subjects in this group will not accept medical interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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healthy lifestyle

food control and intensive exercise to lose weight

Intervention Type BEHAVIORAL

Metformin

use metformin to reduce insulin resistance

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Z Xiao, Doctor

Role: STUDY_DIRECTOR

Beijing Tsinghua Changgeng Hospital

Locations

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BEI JING Tsinghua Changguang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zi Q Zeng, Doctor

Role: CONTACT

0086-010-56118899 ext. 18101127014

Jian Z Xiao, Doctor

Role: CONTACT

0086-010-56118899 ext. 13683685711

Facility Contacts

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jian Z xiao, doctor

Role: primary

0086-010-56118899 ext. 13683685711

References

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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.

Reference Type BACKGROUND
PMID: 25070616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15561905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22385956 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18502303 (View on PubMed)

Other Identifiers

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12015C1023

Identifier Type: -

Identifier Source: org_study_id

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