About this trial
This study aims to explore how anti-obesity medications (AOMs) like semaglutide and tirzepatide affect appetite and energy intake. Researchers will examine two groups: one just starting AOMs and another that has already achieved significant weight loss and maintained it. By conducting meal challenges at different stages of medication use, the study will assess feasibility of the methods and gather preliminary data to design a larger, future study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males and females with a BMI of 30-45 kg/m2 (early group), or a BMI of 30-45 kg/m2 prior to weight loss achieved through medication (late group)
Age, 25-60 years old
Passing medical and physical screening, and analysis of blood and urine screening samples
Anticipated to start or are already prescribed AOMs (semaglutide or tirzepatide)
Disqualifiers
Diagnosed with type 1 or 2 diabetes
Smoker
Previous surgical treatment or device-based therapy for obesity
Chronic or acute pancreatitis
Trial population
Potential participants are residents of the Denver metropolitan area who have either: 1. Had or has obesity and experienced significant weight loss while taking semaglutide or tirzepatide, or 2. Has obesity and has established agreements with their healthcare providers to begin treatment with semaglutide or tirzepatide.
Trial design
Other
Prospective
Treatments tested in this trial
Meal Challenge
Other interventionThe meal challenge scheduled for 4-6 days after the patient's last injection. The study team will insert an indwelling venous catheter into the participant's forearm for serial blood draws. Immediately prior to the meal, participants will consume 1500 mg of acetaminophen (off-label) to facilitate the analysis of gastric emptying. The participant will then begin the meal challenge by eating the test meal, a breakfast casserole, containing 33% of their current resting energy expenditure needs estimated by Mifflin-ST Jeor equation with a composition of 50% carbohydrate, 30% fat and 20% protein. Participants must completely consume the test meal within 25 minutes of initiating the meal. Participants will fill out behavioral questionnaires after consuming the test meal. After the 2-hour blood draw period, participants will be dismissed. Blood will be drawn prior to the meal and at 5, 10, 15, 30, 60, 90, and 120 minutes after initiating the meal.
Treatment groups
Trial outcomes
Primary outcomes
Participant Recruitment
Number of participants recruited for the study.
Meal test tolerability
Number or participants able to tolerate and complete the test meal.
Rate of protocol completion
Percentage of participants enrolled that complete the protocol
Secondary outcomes
Change in peptide YY (pg/ml)
Change in Glucagon Like Peptide-1 (pg/mL)
Change in leptin (ng/mL)
Change in insulin (uIU/mL)
Locations
Sponsors and contacts
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