Obesity/Therapy
Conditions
Keywords
adolescent, adult, brain function, glucagon-like peptide-1 receptor agonists, eating behaviors, appetite sensations
Brief summary
Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.
Interventions
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
DRUGPlacebo
Placebo saline solution subcutaneous
Sponsors
University of Colorado, Denver
University of Minnesota
The Metis Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
study statistician
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* English-speaking * male or female (sex assigned at birth) * 12-18 y/o with obesity (BMI\>120% of the 95th %ile) * 30-45 y/o with obesity (BMI\>35 kg/m2)
Exclusion criteria
* treated with glucagon-like peptide-1 (GLP-1) agonists (e.g., exenatide, liraglutide, semaglutide, tirzepatide) for weight management in the prior 3 months * currently taking anti-psychotic medications (anti-depressants accepted) * diagnosis of type 2 diabetes * current or lifetime anorexia nervosa or current bulimia nervosa * head injury resulting in loss of consciousness \>30min * neurological disorder (e.g., Parkinson's disease) or history of stroke * any contraindication to receiving a MRI (e.g., orthodontal braces) * psychological/behavioral dysfunction (e.g., autism spectrum disorder) or physical impairment that would interfere with study procedures, as determined by study physician * if female, desiring to become pregnant, or currently pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood oxygen-level dependent signal | From enrollment to the end of trial at 32 weeks | measured via resting-state functional magnetic resonance imaging |
| meal kilocalories (kcal) | From enrollment to the end of trial at 32 weeks | Measured as kcal consumed from standardized ad libitum meal |
| visual analogue scale (VAS) score for hunger | From enrollment to the end of trial at 32 weeks | pre- and post-meal hunger measured on a 100mm VAS |
| visual analogue scale (VAS) for desire to eat | From enrollment to end of trial at 32 weeks | pre- and post-meal desire to eat measured on a 100mm VAS |
| visual analogue scale (VAS) score for fullness | From enrollment to end of trial at 32 weeks | pre- and post-meal feeling of fullness measured on a 100mm VAS |
| visual analogue scale (VAS) score for amount participant feels they can eat | From enrollment to end of trial at 32 weeks | pre- and post-meal of amount participant feels they can eat measured on a 100mm VAS |
Countries
United States
Contacts
CONTACTAllison Shapiro, PhD, MPH
CONTACTSean Nilan
PRINCIPAL_INVESTIGATORAllison Shapiro, PhD, MPH
University of Colorado, Denver
Outcome results
None listed