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
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Condition or disease |
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Obesity |
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 |
Group/Cohort |
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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.
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N=600
Cross-sectional study of patients undergoing clinical PET/CT to identify active brown fat. No intervention. Enrolled 405 participants.
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N=220
Longitudinal observational study of obese adolescents to determine changes in adiposity and adipokines during puberty. No intervention. Enrolled 125 participants.
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- Presence of brown adipose tissue [ Time Frame: 2 years ]
- Presence of metabolic dysfunction [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA

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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 |
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.

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
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84108 |
Principal Investigator: | Nicole Mihalopoulos | University of Utah, Department of Pediatrics, Division of Adolescent Medicine |
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 |
Metabolic dysfunction Insulin resistance Brown adipose tissue Dyslipidemia |
Obesity Overnutrition Nutrition Disorders Overweight Body Weight |