STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

Completed

• Conditions: Obesity

• Registration Number: NCT01460784
• Lead Sponsor: University of Utah

Brief Summary

The investigators propose to conduct a cross-sectional study of 60 participants who are 18-30 years of age to undergo research PET/CT. The purpose of this study is to investigate the relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and components of the metabolic syndrome in young adults.

Detailed Description

We propose to conduct a cross-sectional study of 60 participants who are 18-30 years of age to undergo research PET/CT. The purpose of this study is to investigate the relationships between Brown Adipose Tissue (BAT), the adiponectin/leptin (A/L) ratio, and components of the metabolic syndrome in young adults. This study is part of a larger study aimed at understanding the mechanism of brown adipose tissue as a potential protective factor against metabolic dysfunction.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-27
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 575

Inclusion Criteria

• Males and females, 18-30 years of age at enrollment, who are obese (BMI greater or equal to 30 kg/m2, weight less than 159 kg) and healthy
• Without medications and endocrine/genetic disorders known to affect weight.
• Participants may have insulin resistance, impaired glucose tolerance, dyslipidemia, or hypertension.

Exclusion Criteria

• Anyone who refuses participation.
• A genetic syndrome or other endocrine disorder known to cause obesity (Prader-Willi, Cushing Syndrome, Leptin deficiency, etc.).
• Use of the following medications: psychotropics, sulphonylurea, thiazolidinediones, insulin, glucocorticoids, anti-neoplastic agents, angiotensin receptor blocker, angiotensin-converting enzyme inhibitors.
• Pregnancy or history of pregnancy.
• Active infectious disease
• History of CVD or stroke during the previous 36 months
• Total cholesterol 300 mg/dl, triglycerides 400 mg/dl
• Blood pressure 140/90 mmHg
• Fasting plasma glucose 126 mg/dl.
• Diabetes mellitus, type 1 or 2.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of brown adipose tissue	2 years

Secondary Outcome Measures

Name	Time	Method
Presence of metabolic dysfunction	2 years

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States