Metabolomic Profiling in Adolescents With Obesity and Diabetes

University of California San Diego

Status

Completed

Conditions

Diabetic Nephropathies

Metabolomics

Diabetes

Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT02145572

UCSD-IRB-140054

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

13 to 19 years old

Volunteers

Accepts Healthy Volunteers

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