Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents

Pediatric Obesity Clinical Trial

Official title:

Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395003
• Other study ID #: 1503015459
• Secondary ID: 2R01HD028016-20A
• Status: Completed
• Start date: April 2016
• Est. completion date: March 7, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 7, 2023
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Other:
• Palmitate Diet
Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.

Locations

Country	Name	City	State
United States	Yale	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Biopsies	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	MRI	Visceral to Subcutaneous fat storage ratio	Baseline