Metabolomic Profiling in Adolescents With Obesity and Diabetes
NCT ID: NCT02145572
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2014-05-31
2020-07-31
Brief Summary
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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
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Obese adolescents with type 2 diabetes
No intervention
No interventions assigned to this group
Obese adolescents without diabetes
No intervention
No interventions assigned to this group
Healthy non-obese adolescents
No intervention
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
13 Years
19 Years
ALL
Yes
Sponsors
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American Diabetes Association
OTHER
University of California, San Diego
OTHER
Responsible Party
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Dr Jane Kim
Associate Physician, Department of Pediatrics
Principal Investigators
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Jane J Kim, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Rady Children's Hospital
San Diego, California, United States
Countries
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Other Identifiers
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UCSD-IRB-140054
Identifier Type: -
Identifier Source: org_study_id