Metabolomic Profiling in Adolescents With Obesity and Diabetes

Completed

• Conditions: Metabolomics; Obesity; Diabetes; Diabetic Nephropathies

• Registration Number: NCT02145572
• Lead Sponsor: University of California, San Diego

Brief Summary

The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children.

We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Primary Completion: 2019-04
• Study Completion: 2020-07
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age of 13-19 years
• Gender: male and female
• Ethnic background: any
• Obesity will be defined as BMI >95th percentile for age/gender
• Diagnosis of diabetes will be defined by current American Diabetes Association criteria
• Diabetes duration < 2.5 years
• Absence of pancreatic autoimmunity (GAD65 and ICA512 and Insulin autoantibody)
• Adult caregiver willing to actively support study participation
• Signed parental informed consent form and adolescent assent form
• For PCOS substudy, the diagnosis of PCOS will be defined according to the 1990 US National Institute of Health (NIH) criteria (oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and exclusion of other known disorders)

Exclusion Criteria

• Creatinine clearance <60 mL/min (calculated from estimated GFR)
• Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation.
• For PCOS substudy, use of medications that effect androgen levels in the blood (i.e. oral contraceptive pills, or metformin) for the last 3 months prior to enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in metabolite concentrations measured by mass spectrometry, comparing blood and urine samples from obese adolescents with type 2 diabetes, obese adolescents without diabetes, and age-matched healthy non-obese controls.	2 years

Trial Locations

Locations (1)

Rady Children's Hospital; 🇺🇸 San Diego, California, United States