Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes

NCT ID: NCT02843139

Last Updated: 2016-07-25

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

COMPLETED

Total Enrollment

535 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

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Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood. Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese children at risk for diabetes in future.

Detailed Description

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This study was designed to screen the circulating miRNAs in association with progression from children obesity to type 2 diabetes (T2D) in adulthood. Serum samples were evaluated in a 3 step procedure: 1) discovery study, in which samples from obese children and healthy controls were pooled for miRNA sequecing experiment; 2) cross-sectional validation study, in which miRNAs of interest were validated in all individuals (obese children, overweight children and normal controls); 3) longitudinal validation study, in which the candidate miRNAs were estimated in newly diagnosed diabetes patients and normal glucose tolerance controls (NGT). The final determined miRNAs were further confirmed though primary function studies.

Conditions

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Discriminate Obese Children at Risk for Diabetes.

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children group

Children recruiters were categorized into three groups: obesity, overweight and normal control based on World Health Organization child growth standards.

No interventions assigned to this group

Adults group

Adults with type 2 diabetes were defined if the individual had a fasting plasma glucose (FPG) level ≥ 7.0 mmol/L.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Obese preschoolers; Adults with type 2 diabetes; Age-matched healthy controls.

Exclusion Criteria

\-
Minimum Eligible Age

48 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xirong Guo

Vice-president

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NMU-201487

Identifier Type: -

Identifier Source: org_study_id

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