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Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes

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ClinicalTrials.gov Identifier: NCT02843139
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Xirong Guo, Nanjing Medical University

Brief 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.

Condition or disease
Discriminate Obese Children at Risk for Diabetes.

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.

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Study Type : Observational
Actual Enrollment : 535 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Circulating microRNAs as Novel Prognostic Biomarkers in Obese Preschoolers at Risk for Type 2 Diabetes in Adulthood
Study Start Date : April 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

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.



Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Whole blood, Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   48 Months to 72 Months   (Child)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843139


Locations
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China, Jiangsu
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
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Responsible Party: Xirong Guo, Vice-president, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02843139    
Other Study ID Numbers: NMU-201487
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xirong Guo, Nanjing Medical University:
Circulating microRNA
Childhood obesity
Adulthood diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases