Pediatric ObesityNCT02395003
Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents
An observational study of Pediatric Obesity, run by Yale University at 1 site in United States.
Trial summary
Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2 diabetes. The present studies will focus on determining what might cause fat to accumulate in the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to develop in obese adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Palmitate Diet
- Type of treatment
- Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 7 Mar 2023
- How long will I take part?
- 12 Weeks
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Obese adolescents
Who may be able to join
- Overweight (85-95th% age and gender specific) or Obese (>95th% age and gender specific)
- Ages 12-18 years
- Absence of any endocrinopathy
- Absence of any therapy with medication known to alter glucose metabolism (i.e.: Oral steroids, certain psychiatric medications such as Xeleca, Lithium, Paxil)
- English Speaking subjects
Who cannot join
- Any disease known to alter glucose metabolism (T2DM)
- Diuretic Medication
- Pregnant or breastfeeding
- Type 1 or 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2 diabetes. The present studies will focus on determining what might cause fat to accumulate in the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to develop in obese adolescents.
Read the detailed description
The purpose of this study is to test whether the reduced transcription of key lipogenic/adipogenic genes in abdominal subcutaneous adipose tissue (SAT) in obese adolescents with a High VAT/SAT (visceral adipose tissue/subcutaneous adipose tissue) ratio translates functionally into a reduced in vivo triglyceride (TG) synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and insulin resistance (IR). To test whether the storage capacity of gluteal SAT is linked to the level of VAT/SAT fat distribution in obese adolescents. To explore if changes in dietary fat intake (palmitate intake) alters ceramide concentration in both plasma and adipose tissue (AT) and the Inflammasome complex in the different fat distribution phenotypes and their associations with IR.
- Conditions
- Pediatric Obesity
- Being tested
- Palmitate Diet
- Keywords
- Obesity, Pediatric
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmitate DietOther
Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.
| Study group | Role | What they receive |
|---|---|---|
| High VAT/SAT high Palmitate Diet | Subjects with a high ratio of visceral to subcutaneous fat consuming high Palmatite oil diet for 12 weeks Receives: Other: Palmitate Diet | |
| Low VAT/SAT | Subjects with a low ratio of visceral to subcutaneous fat Receives: Other: Palmitate Diet | |
| Lean Controls | Lean control | |
| High VAT/SAT- low Palmitate Diet | Subjects with a high ratio of visceral to subcutaneous fat consuming low Palmatite oil diet for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Biopsies
- To test whether the reduced transcription of key lipogenic/adipogenic genes in abd SAT in obese adolescents with a High VAT/SAT ratio translates functionally into a reduced in vivo TG synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and IR.
Measured: Baseline
Secondary outcomes (1)
MRI
Visceral to Subcutaneous fat storage ratio
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startApr 2016
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sonia Caprio, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395003
- Sponsor's protocol ID
- 1503015459
- Other IDs
- 2R01HD028016-20A1, 2R01HD028016
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2015
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02395003
- Acronym / sponsor ID
- 1503015459
- Conditions
- Pediatric Obesity
- Keywords
- Obesity, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2016
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 20 Mar 2015 (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.
Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2 diabetes. The present studies will focus on determining what might cause fat to accumulate in the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to develop in obese adolescents.
Detailed description
The purpose of this study is to test whether the reduced transcription of key lipogenic/adipogenic genes in abdominal subcutaneous adipose tissue (SAT) in obese adolescents with a High VAT/SAT (visceral adipose tissue/subcutaneous adipose tissue) ratio translates functionally into a reduced in vivo triglyceride (TG) synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and insulin resistance (IR). To test whether the storage capacity of gluteal SAT is linked to the level of VAT/SAT fat distribution in obese adolescents. To explore if changes in dietary fat intake (palmitate intake) alters ceramide concentration in both plasma and adipose tissue (AT) and the Inflammasome complex in the different fat distribution phenotypes and their associations with IR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High VAT/SAT high Palmitate Diet | – | Other: Palmitate DietSubjects with a high ratio of visceral to subcutaneous fat consuming high Palmatite oil diet for 12 weeks |
| Low VAT/SAT | – | Other: Palmitate DietSubjects with a low ratio of visceral to subcutaneous fat |
| Lean Controls | – | –Lean control |
| High VAT/SAT- low Palmitate Diet | – | –Subjects with a high ratio of visceral to subcutaneous fat consuming low Palmatite oil diet for 12 weeks |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Obese adolescents
Key inclusion criteria (5 listed)
- Overweight (85-95th% age and gender specific) or Obese (>95th% age and gender specific)
- Ages 12-18 years
- Absence of any endocrinopathy
- Absence of any therapy with medication known to alter glucose metabolism (i.e.: Oral steroids, certain psychiatric medications such as Xeleca, Lithium, Paxil)
- English Speaking subjects
Key exclusion criteria (4 listed)
- Any disease known to alter glucose metabolism (T2DM)
- Diuretic Medication
- Pregnant or breastfeeding
- Type 1 or 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palmitate DietSubject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet. | Other | High VAT/SAT high Palmitate Diet, Low VAT/SAT |
Primary outcome
Fat Biopsies
Time frame: Baseline
1) To test whether the reduced transcription of key lipogenic/adipogenic genes in abd SAT in obese adolescents with a High VAT/SAT ratio translates functionally into a reduced in vivo TG synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and IR.
1 secondary outcome
MRI
Time frame: Baseline
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 26 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Sonia Caprio, MD principal investigator
Yale University
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 Pediatric Obesity, run by Yale University 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 5 inclusion and 4 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 26 Feb 2024. 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?
Fat Biopsies (time frame: Baseline). 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 26 Feb 2024.