Metabolomic Profiling in Adolescents With Obesity and Diabetes

November 2, 2020 updated by: Dr Jane Kim, University of California, San Diego

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from clinical practices affiliated with Rady Children's Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obese adolescents with type 2 diabetes
No intervention
Obese adolescents without diabetes
No intervention
Healthy non-obese adolescents
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 2 years
2 years

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Jane J Kim, MD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 23, 2014

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSD-IRB-140054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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