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

ConditionObesity; Drug
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-60
SponsorUniversity of Colorado, Denver

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Meal Challenge

    Other intervention

    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.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Early Group1 intervention
Group B: Late Group1 intervention

Trial outcomes

Primary outcomes

1

Participant Recruitment

Number of participants recruited for the study.

Time frame
6-10 weeks
2

Meal test tolerability

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

Time frame
6-10 weeks
3

Rate of protocol completion

Percentage of participants enrolled that complete the protocol

Time frame
6-10 weeks

Secondary outcomes

1

Change in peptide YY (pg/ml)

Time frame
6-10 weeks
2

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

Time frame
6-10 weeks
3

Change in leptin (ng/mL)

Time frame
6-10 weeks
4

Change in insulin (uIU/mL)

Time frame
6-10 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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