Impact of Antiobesity Medications on Appetite and Appetite-related Hormones and Metabolites.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Participant Recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosed with type 1 or 2 diabetes
- •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
结局指标
主要结局
Participant Recruitment
时间窗: 6-10 weeks
Number of participants recruited for the study.
Meal test tolerability
时间窗: 6-10 weeks
Number or participants able to tolerate and complete the test meal.
Rate of protocol completion
时间窗: 6-10 weeks
Percentage of participants enrolled that complete the protocol
次要结局
- Change in leptin (ng/mL)(6-10 weeks)
- Change in peptide YY (pg/ml)(6-10 weeks)
- Change in Glucagon Like Peptide-1 (pg/mL)(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(6-10 weeks)
- Eating Rate(6-10 weeks)
- Changes in subjective hunger by visual analog scale (VAS)(6-10 weeks)
- Changes in subjective fullness by visual analog scale (VAS)(6-10 weeks)
- Changes in perceived prospective food consumption by visual analog scale (VAS)(6-10 weeks)
- Changes in subjective nausea by visual analog scale (VAS)(6-10 weeks)
- Disinhibition measured by TFEQ(6-10 weeks)
研究者
Mark Ezpeleta
Post Doctoral Fellow
University of Colorado, Denver