STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

Study Overview
=================
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.

Official Title
-----------------
Changes in Adipokines and Adiposity During Puberty and Young Adulthood

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| N=60<br>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<br>Cross-sectional study of patients undergoing clinical PET/CT to identify active brown fat. No intervention. Enrolled 405 participants. | |
| N=220<br>Longitudinal observational study of obese adolescents to determine changes in adiposity and adipokines during puberty. No intervention. Enrolled 125 participants. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of brown adipose tissue |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of metabolic dysfunction |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic dysfunction, Insulin resistance, Brown adipose tissue, Dyslipidemia