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Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients
Our overall goal is to determine the effect of Phentermine and Topiramate ER on gastric emptying, gastric accommodation, satiety, and satiation in obese participants.
Details
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2013-04 |
| Completion | 2014-03 |
Conditions
- Obesity
Interventions
- Phentermine-Topiramate ER
- Placebo
Primary outcomes
- Gastric Emptying of Solids Half-Time (T 1/2) — 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. - Fasting Gastric Volume — 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 — 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 — 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 — 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. - Buffet Meal Intake — 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.
Countries
United States