STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Utah.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 29, 2014