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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Group | Participants in the early group are individuals that have established agreements with their clinical providers to begin treatment with semaglutide or tirzepatide as part of their ongoing weight management strategy. These participants will complete a meal challenge before they start the medication and 6 weeks after starting medication. |
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| Late Group | Participants in the late group are individuals that have lost >12% of their body weight on either semaglutide or tirzepatide and are still taking the medication. These participants will complete a meal challenge before they discontinue medication and 3 weeks after discontinuing the medication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal Challenge | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Recruitment | Number of participants recruited for the study. | 6-10 weeks |
| Meal test tolerability | Number or participants able to tolerate and complete the test meal. | 6-10 weeks |
| Rate of protocol completion | Percentage of participants enrolled that complete the protocol | 6-10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peptide YY (pg/ml) | 6-10 weeks | |
| Change in Glucagon Like Peptide-1 (pg/mL) | 6-10 weeks | |
| Change in leptin (ng/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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Potential participants are residents of the Denver metropolitan area who have either:
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Blood
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| 6-10 weeks |
| Change in insulin (uIU/mL) | 6-10 weeks |
| Change in Glucagon (pg/mL) | 6-10 weeks |
| Glucose-Dependent Insulinotropic Peptide (pg/mL) | 6-10 weeks |
| 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 | Peak acetaminophen concentration in blood | 6-10 weeks |
| Eating Rate | Calories/minutes | 6-10 weeks |
| Changes in subjective hunger by visual analog scale (VAS) | Line from 0: not hungry to 10: extremely hungry | 6-10 weeks |
| Changes in subjective fullness by visual analog scale (VAS) | Line from 0: not full to 10: extremely full | 6-10 weeks |
| Changes in perceived prospective food consumption by visual analog scale (VAS) | Line from 0: no desire to eat more to 10: I could eat a large amount. | 6-10 weeks |
| Changes in subjective nausea by visual analog scale (VAS) | Line from 0: no nausea at all more to 10: worst nausea possible. | 6-10 weeks |
| Disinhibition measured by TFEQ | Disinhibition | 6-10 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |