Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents

NCT ID: NCT02395003

Last Updated: 2024-02-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2023-03-07

Brief Summary

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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

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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

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Pediatric Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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High VAT/SAT high Palmitate Diet

Subjects with a high ratio of visceral to subcutaneous fat consuming high Palmatite oil diet for 12 weeks

Palmitate Diet

Intervention Type OTHER

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

Palmitate Diet

Intervention Type OTHER

Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.

Lean Controls

Lean control

No interventions assigned to this group

High VAT/SAT- low Palmitate Diet

Subjects with a high ratio of visceral to subcutaneous fat consuming low Palmatite oil diet for 12 weeks

No interventions assigned to this group

Interventions

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Palmitate Diet

Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonia Caprio, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2R01HD028016-20A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R01HD028016

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1503015459

Identifier Type: -

Identifier Source: org_study_id

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