Summary

for people ages 13-19 (full criteria)
healthy people welcome
at San Diego, California
study started
estimated completion:
Jane J Kim

Description

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.

Keywords

Metabolomics Obesity Diabetes Diabetic Nephropathies Diabetes Mellitus

Eligibility

You can join if…

Open to people ages 13-19

  • 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)

You CAN'T join if...

  • 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

Location

  • Rady Children's Hospital
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02145572
Lead Scientist
Jane J Kim
Study Type
Observational
Last Updated
June 18, 2018