NCT07299084进行中（未招募）1 期
A Study to Evaluate the Effect of Fasting Duration and Temporary Withholding of Tirzepatide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal
研究概览
简要总结
The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal. Ultrasound will be used to check the stomach content after a test meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet one of the following criteria:
- •Have type 2 diabetes
- •Have obesity
- •Have overweight with at least one health issue related to weight but without type 2 diabetes
排除标准
- •Have a condition that affects how their stomach empties
- •Have had weight loss surgery
- •Have type 1 diabetes
- •Have any major medical conditions or histories that could interfere with the study
研究组 & 干预措施
Participants with Overweight or Obesity Without Type 2 Diabetes
Experimental
Participants will receive tirzepatide SC
干预措施: Tirzepatide (Drug)
Participants with Type 2 Diabetes
Experimental
Participants will receive tirzepatide subcutaneously (SC)
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal
时间窗: Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal)
次要结局
- Percentage of Participants with Lack of Gastric Content Retention Post-Liquid Test Meal(Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal))
- Amount of Gastric Content Volume Post-Liquid Test Meal(Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal))
- Amount of Gastric Content Volume Post-Solid Test Meal(Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal))
- Percentage of Participants with Lack of Gastric Content Retention Post-Solid Test Meal After Discontinuation of Tirzepatide(Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours)
- Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Solid Test Meal(Baseline, Day 171 (at 6, 8, 12, 18 and 24 hours after baseline or Day 170 solid test meal))
- Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale Post-Liquid Test Meal(Day 178 (at 6, 8, 12, 18 and 24 hours after Day 177 liquid test meal)])
- Percentage of Participants with Grades 0, 1, and 2 from Antrum Grading Scale After Discontinuation of Tirzepatide(Baseline through 8 days after discontinuation of tirzepatide at 6, 8, 12,18 and 24 hours)
研究者
研究点 (1)
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