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STAGES Trial: Study of Adiposity, Growth and Endocrine Stages (STAGES)

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ClinicalTrials.gov Identifier: NCT01460784
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : December 3, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nicole L. Mihalopoulos, University of Utah

Study Description
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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.

Condition or disease
Obesity

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 Design
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Study Type : Observational
Actual Enrollment : 575 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Changes in Adipokines and Adiposity During Puberty and Young Adulthood
Study Start Date : June 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015
Groups and Cohorts
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Group/Cohort
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.
N=600
Cross-sectional study of patients undergoing clinical PET/CT to identify active brown fat. No intervention. Enrolled 405 participants.
N=220
Longitudinal observational study of obese adolescents to determine changes in adiposity and adipokines during puberty. No intervention. Enrolled 125 participants.


Outcome Measures
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Primary Outcome Measures :
  1. Presence of brown adipose tissue [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Presence of metabolic dysfunction [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Buffy coat in -80F long-term storage

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy, obese young adults
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460784


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Nicole Mihalopoulos University of Utah, Department of Pediatrics, Division of Adolescent Medicine
More Information
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Responsible Party: Nicole L. Mihalopoulos, Associate Professor of Pediatrics, University of Utah
ClinicalTrials.gov Identifier: NCT01460784    
Other Study ID Numbers: IRB_00031720
1K23HL092069-01A2 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Nicole L. Mihalopoulos, University of Utah:
Metabolic dysfunction
Insulin resistance
Brown adipose tissue
Dyslipidemia
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms