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STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

NCT ID: NCT01460784

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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N=60

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

No interventions assigned to this group

N=600

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

No interventions assigned to this group

N=220

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Nicole L. Mihalopoulos

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Mihalopoulos

Role: PRINCIPAL_INVESTIGATOR

University of Utah, Department of Pediatrics, Division of Adolescent Medicine

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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1K23HL092069-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB_00031720

Identifier Type: -

Identifier Source: org_study_id