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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nicole L. Mihalopoulos, University of Utah
ClinicalTrials.gov Identifier:
NCT01460784
First received: October 25, 2011
Last updated: December 1, 2015
Last verified: December 2015
  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 ]

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

Enrollment: 575
Study Start Date: June 2010
Study Completion Date: March 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Locations
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
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: December 1, 2015
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 February 08, 2016