Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents

February 22, 2024 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Obese adolescents

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any disease known to alter glucose metabolism (T2DM)
  • Diuretic Medication
  • Pregnant or breastfeeding
  • Type 1 or 2 diabetes

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
Intervention / Treatment
High VAT/SAT high Palmitate Diet
Subjects with a high ratio of visceral to subcutaneous fat consuming high Palmatite oil diet for 12 weeks
Other: Palmitate Diet
Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.
Low VAT/SAT
Subjects with a low ratio of visceral to subcutaneous fat
Other: Palmitate Diet
Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI
Time Frame: Baseline
Visceral to Subcutaneous fat storage ratio
Baseline

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Sonia Caprio, MD, Yale University

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

April 1, 2016

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimated)

March 20, 2015

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1503015459
  • 2R01HD028016-20A1 (U.S. NIH Grant/Contract)
  • 2R01HD028016 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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