Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.

N/ANot Yet RecruitingNCT06856928

University of Colorado, Denver16 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity; Drug

Interventions

Meal ChallengeOTHER

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Participant Recruitment

Number of participants recruited for the study.

Time frame: 6-10 weeks

Meal test tolerability

Number or participants able to tolerate and complete the test meal.

Time frame: 6-10 weeks

Rate of protocol completion

Percentage of participants enrolled that complete the protocol

Time frame: 6-10 weeks

Secondary Outcomes

Change in peptide YY (pg/ml)

Time frame: 6-10 weeks

Change in Glucagon Like Peptide-1 (pg/mL)

Time frame: 6-10 weeks

Change in leptin (ng/mL)

Time frame: 6-10 weeks

Change in insulin (uIU/mL)

Time frame: 6-10 weeks

Change in Glucagon (pg/mL)

Time frame: 6-10 weeks

Glucose-Dependent Insulinotropic Peptide (pg/mL)

Time frame: 6-10 weeks

Change in Glucose (mg/dL)

Time frame: 6-10 weeks

Change in triglycerides (mg/dL)

Time frame: 6-10 weeks

Data from ClinicalTrials.gov

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