Obesity; Drug
Conditions
Keywords
appetite-related hormones, appetite, metabolites
Brief summary
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.
Interventions
OTHERMeal Challenge
The 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.
Sponsors
University of Colorado, Denver
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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) * 6-months weight stable (early group) or 3 months weight stable at current weight (late group) * Women of reproductive age must be using an effective form of contraception
Exclusion criteria
* Diagnosed with type 1 or 2 diabetes * Smoker * Previous surgical treatment or device-based therapy for obesity * Chronic or acute pancreatitis * Clinically significant gastric emptying abnormality * Uncontrolled hypertension or hypo/hyperthyroidism * Cardiovascular event 3 months within screening * Acute or chronic hepatitis * Inability to tolerate beef, eggs, and cheese * Women who are pregnant * Women who are nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Recruitment | 6-10 weeks | Number of participants recruited for the study. |
| Meal test tolerability | 6-10 weeks | Number or participants able to tolerate and complete the test meal. |
| Rate of protocol completion | 6-10 weeks | Percentage of participants enrolled that complete the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glucose (mg/dL) | 6-10 weeks | — |
| Change in triglycerides (mg/dL) | 6-10 weeks | — |
| Change in free fatty acids (uEq/L) | 6-10 weeks | — |
| Change in Total Cholesterol (mg/dL) | 6-10 weeks | — |
| Gastric emptying by acetaminophen | 6-10 weeks | Peak acetaminophen concentration in blood |
| Eating Rate | 6-10 weeks | Calories/minutes |
| Changes in subjective hunger by visual analog scale (VAS) | 6-10 weeks | Line from 0: not hungry to 10: extremely hungry |
| Change in insulin (uIU/mL) | 6-10 weeks | — |
| Change in Glucagon Like Peptide-1 (pg/mL) | 6-10 weeks | — |
| Change in leptin (ng/mL) | 6-10 weeks | — |
| Changes in subjective fullness by visual analog scale (VAS) | 6-10 weeks | Line from 0: not full to 10: extremely full |
| Changes in perceived prospective food consumption by visual analog scale (VAS) | 6-10 weeks | Line from 0: no desire to eat more to 10: I could eat a large amount. |
| Changes in subjective nausea by visual analog scale (VAS) | 6-10 weeks | Line from 0: no nausea at all more to 10: worst nausea possible. |
| Disinhibition measured by TFEQ | 6-10 weeks | Disinhibition |
| Change in peptide YY (pg/ml) | 6-10 weeks | — |
| Change in Glucagon (pg/mL) | 6-10 weeks | — |
| Glucose-Dependent Insulinotropic Peptide (pg/mL) | 6-10 weeks | — |
Outcome results
None listed