STAGES Trial: Study of Adiposity, Growth and Endocrine Stages

NCT01460784 | Completed DMC

• 2 other identifiers: IRB_000317201K23HL092069-01A2
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Metabolic dysfunction; Insulin resistance; Brown adipose tissue; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Presence of brown adipose tissue

  2 years

Secondary Outcomes (1)

• Presence of metabolic dysfunction

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, obese young adults

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat in -80F long-term storage

MeSH Terms

Conditions

Obesity; Insulin Resistance; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders

Study Officials

• Nicole Mihalopoulos

  University of Utah, Department of Pediatrics, Division of Adolescent Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: June 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)