Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes

July 22, 2016 updated by: Xirong Guo, Nanjing Medical University

Circulating microRNAs as Novel Prognostic Biomarkers in Obese Preschoolers at Risk for Type 2 Diabetes in Adulthood

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

535

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
50-70 month old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-201487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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