Metabolomic Profiling in Adolescents With Obesity and Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02145572

Enrollment

Registered

2014-05-23

Start date

2014-05-31

Completion date

2020-07-31

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetic Nephropathies, Metabolomics, Obesity

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

13 Years to 19 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Other

Measure	Time frame
Validation of presence of DENND1A isoform in the urine of adolescent females with polycystic ovarian syndrome	2 years

Countries

United States

Outcome results