STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

This study is currently recruiting participants.
Verified June 2012 by University of Utah
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nicole L. Mihalopoulos, University of Utah
ClinicalTrials.gov Identifier:
NCT01460784
First received: October 25, 2011
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Changes in Adipokines and Adiposity During Puberty and Young Adulthood

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Presence of brown adipose tissue [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of metabolic dysfunction [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460784

Contacts
Contact: Nicole Mihalopoulos 801-585-6334 nicole.mihalopoulos@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Nicole L Mihalopoulos, MD    801-585-6334    nicole.mihalopoulos@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Nicole Mihalopoulos University of Utah, Department of Pediatrics, Division of Adolescent Medicine
  More Information

No publications provided

Responsible Party: Nicole L. Mihalopoulos, Associate Professor of Pediatrics, University of Utah
ClinicalTrials.gov Identifier: NCT01460784     History of Changes
Other Study ID Numbers: IRB_00031720, 1K23HL092069-01A2
Study First Received: October 25, 2011
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Metabolic dysfunction
Insulin resistance
Brown adipose tissue
Dyslipidemia

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014