Metabolomic Profiling in Adolescents With Obesity and Diabetes

Obesity Clinical Trial

Official title:

Metabolomic Profiling in Adolescents With Obesity and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145572
• Other study ID #: UCSD-IRB-140054
• Status: Completed
• Start date: May 2014
• Est. completion date: July 2020

Study information

• Verified date: November 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetic Nephropathies
• Metabolomics
• Obesity

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Validation of presence of DENND1A isoform in the urine of adolescent females with polycystic ovarian syndrome		2 years
Primary	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