MetabolomicsNCT02145572
Metabolomic Profiling in Adolescents With Obesity and Diabetes
An observational study of Metabolomics and Obesity, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolomics, Obesity, Diabetes
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects will be recruited from clinical practices affiliated with Rady Children's Hospital.
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital
San Diego, California, 92123
About this study
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.
- Conditions
- Metabolomics, Obesity, Diabetes, Diabetic Nephropathies
- Medical subject headings
- Obesity, Diabetes Mellitus, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese adolescents with type 2 diabetes | No intervention | |
| Obese adolescents without diabetes | No intervention | |
| Healthy non-obese adolescents | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolomicsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Dr Jane Kim, University of California, San Diego
- Investigators
- Jane J Kim, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145572
- Sponsor's protocol ID
- UCSD-IRB-140054
- Status last verified
- Nov 2020
- First submitted
- 19 May 2014
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiling in Adolescents With Obesity and Diabetes
- ClinicalTrials.gov ID
- NCT02145572
- Acronym / sponsor ID
- UCSD-IRB-140054
- Conditions
- Metabolomics, Obesity, Diabetes, Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- May 2014
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese adolescents with type 2 diabetes | – | –No intervention |
| Obese adolescents without diabetes | – | –No intervention |
| Healthy non-obese adolescents | – | –No intervention |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be recruited from clinical practices affiliated with Rady Children's Hospital.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane J Kim, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolomics and Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.