STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Obesity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01460784

1K23HL092069-01A2 (U.S. NIH Grant/Contract)

IRB_00031720

Details and patient eligibility

About

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.

Full 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.

Enrollment: 575 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

575 participants in 3 patient groups

N=60

Description:

Cross-sectional study of obese young adults who underwent PET/CT after cold exposure to identify active brown fat. No intervention. Enrolled 44 participants.

N=600

Description:

Cross-sectional study of patients undergoing clinical PET/CT to identify active brown fat. No intervention. Enrolled 405 participants.

N=220

Description:

Longitudinal observational study of obese adolescents to determine changes in adiposity and adipokines during puberty. No intervention. Enrolled 125 participants.