Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gastric Emptying of Solids Half-Time (T 1/2)
研究概览
简要总结
Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric emptying, gastric accommodation, satiety, and satiation in obese participants.
详细描述
Investigators propose a randomized controlled trial of combination phentermine topiramate ER versus placebo given orally for 10-15 days.
At visit 1 subjects had a brief interview, body measurements, and completed 4 questionnaires to rule out any gastrointestinal or significant psychological distress.
At visit 2 subjects did a satiation/nutrient drink test. They drank a nutrient drink until they reached the maximum volume that could be tolerated, symptoms were recorded and blood samples taken at 4 times. They were randomized to one of the arms, and received a 5 day supply of study medication or placebo. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5.
At visit 3 subjects returned to pick up a nine day supply of study medication or placebo. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
At visit 4 subjects underwent imaging to measure the volume of their stomach with an external camera that revolved around abdomen while they were lying on a table. Stomach volume was checked during fasting, starting 10 min after an intravenous injection of a radioactive material. The subjects ingested more of the liquid nutrient drink and 2 more images were obtained over 30 minutes. On the same day, subjects participated in an all you can eat meal, starting 4 hours after the ingestion of the liquid nutrient drink.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phentermine-Topiramate ER
Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
干预措施: Phentermine-Topiramate ER (Drug)
Placebo
Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
干预措施: Placebo (Drug)
结局指标
主要结局
Gastric Emptying of Solids Half-Time (T 1/2)
时间窗: Day 15, approximately 2 hours after radiolabeled meal was ingested
Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals.
Buffet Meal Intake
时间窗: Day 13, approximately 4.5 hours after liquid meal
At visit 4 subjects underwent imaging to measure the volume of their stomach, fasting and after ingesting a liquid nutrient drink. Four hours after the liquid meal, subjects were invited to eat, over a 30-minute period, a standard "all you can eat" meal vegetable lasagna, vanilla pudding, and skim milk. The total Kcal of the food consumed was analyzed by using validated software.
Fasting Gastric Volume
时间窗: Day 13, approximately 10 minutes after Technetium (99mTC) injection
Fasting whole gastric volume was measured by Technetium (99mTc)-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.
Postprandial Gastric Volume
时间窗: Day 13, approximately 30 minutes after liquid meal
Postprandial gastric volume was measured by 99mTc-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. After the liquid meal tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.
Volume to Fullness
时间窗: Day 14, approximately 30 minutes after liquid meal
At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.
Maximum Tolerated Volume
时间窗: Day 14, approximately 30 minutes after liquid meal
At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reached level 5.
次要结局
- Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)(Day 14, approximately 45 minutes after liquid meal)
- Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours(Day 15, approximately 2 hours after radiolabeled meal was ingested)
- Solid Gastric Emptying: Proportion Remaining at 4 Hours(Day 15, approximately 4 hours after radiolabeled meal was ingested)
- Change in Postprandial Gastric Volume(Day 13, approximately approximately 30 min after liquid meal)
- Fasting Ghrelin(Day 14, before liquid meal)
- Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)(Day 14, approximately 45 minutes after liquid meal)
- Peak Postprandial Level of Cholecystokinin (CCK)(Day 14, approximately 45 minutes after liquid meal)
研究者
Michael Camilleri
Primary Investigator
Mayo Clinic