NCT02502344

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

July 15, 2015

Last Update Submit

July 19, 2016

Conditions

Keywords

insulin resistanceabnormal glucose toleranceDM prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

medical intervention group

EXPERIMENTAL

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 lifestyleDrug: Metformin

clinical observeral group

NO INTERVENTION

subjects in this group will not accept medical interventions

Interventions

food control and intensive exercise to lose weight

medical intervention group

use metformin to reduce insulin resistance

medical intervention group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BEI JING Tsinghua Changguang Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 25070616BACKGROUND
  • 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.

    PMID: 15561905BACKGROUND
  • 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.

    PMID: 22385956BACKGROUND
  • 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.

    PMID: 18502303BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jian Z Xiao, Doctor

    Beijing Tsinghua Changgeng Hospital

    STUDY DIRECTOR

Central Study Contacts

Zi Q Zeng, Doctor

CONTACT

Jian Z Xiao, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 20, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2018

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations