Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents

Completed

• Conditions: Pediatric Obesity
• Interventions: Other: Palmitate Diet

• Registration Number: NCT02395003
• Lead Sponsor: Yale University

Brief 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.

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 Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Study Start: 2016-04
• Primary Completion: 2023-03-07
• Study Completion: 2023-03-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High VAT/SAT high Palmitate Diet	Palmitate Diet	Subjects with a high ratio of visceral to subcutaneous fat consuming high Palmatite oil diet for 12 weeks
Low VAT/SAT	Palmitate Diet	Subjects with a low ratio of visceral to subcutaneous fat

Primary Outcome Measures

Name	Time	Method
Fat Biopsies	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.

Secondary Outcome Measures

Name	Time	Method
MRI	Baseline	Visceral to Subcutaneous fat storage ratio

Trial Locations

Locations (1)

Yale; 🇺🇸 New Haven, Connecticut, United States