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CompletedNCT02843139Updated Jul 25, 2016

Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes

An observational study in Discriminate Obese Children at Risk for Diabetes., sponsored by Nanjing Medical University. Completed at 1 site in China. Open to participants aged 48 Months to 72 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-25.

Sponsored by Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
535
Ages
48 Months to 72 Months
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Discriminate Obese Children at Risk for Diabetes.

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Keywords

  • Circulating microRNA
  • Childhood obesity
  • Adulthood diabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 535 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Months to 72 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children recruiters were categorized into three groups: obesity, overweight and normal control based on World Health Organization child growth standards. Adults with type 2 diabetes were defined if the individual had a fasting plasma glucose (FPG) level ≥ 7.0 mmol/L.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
535 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Children group

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

  • Adults group

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

06

What researchers measure

Primary outcomes

  1. It is expected that the identification of circulating miRNAs as potential biomarkers may facilitate to the diagnosis of obese preschoolers at high risk for developing diabetes.

    Time frame: 50-70 month old

07

Study locations

1 site
  • Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
    Nanjing, Jiangsu 210004, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02843139
Lead sponsor
Nanjing Medical University
Responsible party
Xirong Guo (Vice-president, Nanjing Medical University) — Principal investigator
First posted
Jul 25, 2016
Start date
Apr 2014
Primary completion
Oct 2015
Completion
Mar 2016
Last update
Jul 25, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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