A Phase 4 interventional study of Exenatide and Placebo in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-09.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
The overall goal of this study was to determine the effect of exenatide on gastric emptying, satiety and satiation in obese participants. The hypothesis in this study was that exenatide retards gastric emptying in obese patients with baseline accelerated gastric emptying.
This study evaluated the effect of exenatide 5mcg subcutaneous (SQ) twice daily for 30-days versus placebo on gastric emptying, satiety, satiation and weight loss in obese participants with documented accelerated gastric emptying of solids.
Visit 1: Screening - physical exam, questionnaires, pregnancy test. Participants were instructed to continue on the same diet and exercise routine during the entire study.
Visit 2: Satiation Study Day - Subjects returned to the clinic after after fasting for at least 8 hours. A baseline satiation/nutrient drink test was performed on Day 0 prior to initiation of exenatide or placebo. The satiation/nutrient drink test involved drinking a liquid meal (Ensure) at a rate of one ounce per minute until no more could be ingested. At the same time, subject's symptoms were recorded while they drank the liquid meal and for 30 minutes after they reached the maximum volume tolerated. Subjects were randomized to exenatide or placebo, then received 30 days' supply of blinded study medication.
Visit 3: Satiation Study Day - (This test was performed in the last 5 days of the 30 days of medication administration.) Subjects returned to the clinic after after fasting for at least 8 hours. Subjects were instructed to inject exenatide or placebo 30 minutes before the start of the satiation/nutrient drink test. The satiation/nutrient drink test was repeated.
Visit 4: Gastric Emptying by Scintigraphy Day - (This test was performed in the last 5 days of the 30 days of medication administration.) Subjects returned to the clinic after after fasting for at least 8 hours. Subjects were instructed to inject exenatide or placebo 30 minutes before the start of the gastric emptying test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contain a small amount of radioactive substance. At the completion of the breakfast test meal, subjects were instructed to stand in front of a special camera and pictures were taken at specific intervals. On the same day, subjects participated in an all you can eat meal. This meal consists of lasagna, pudding, and skim milk. Food containers were weighed after the meal and calories consumed were estimated using validated dietary software.
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Exclusion Criteria:
Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
Drug: Exenatide
Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Drug: Placebo
5 mcg exenatide subcutaneously twice daily for 30 days
Also known as: Byetta
placebo subcutaneously twice daily for 30 days
Gastric Emptying Half-time (T 1/2) of Solids
Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).
Time frame: time frame is 30 days after the initiation of dose.
Percentage of Gastric Contents Emptied at 1 Hour
Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.
Time frame: Visit 4, approximately 1 hours after radiolabeled meal was ingested
Change in Body Weight
Time frame: baseline, day 30
Satiation Expressed as Volume to Fullness
In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) 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.
Time frame: Visit 3, approximately 30 minutes after liquid meal
Maximum Tolerated Volume
In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) 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 5.
Time frame: Visit 3, approximately 30 minutes after liquid meal
Buffet Meal Intake (kcal)
Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard "all you can eat" meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software.
Time frame: Visit 4, approximately 30 minutes after start of "all you can eat" meal
Aggregate Satiation Symptom Score
Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from "none"(0) to "worst ever" (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating "none" and 400 indicating "worst ever."
Time frame: Visit 3, approximately 30 min after ingestion of nutrient drink test
| Milestone | Exenatide | Placebo |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).
| minutes | Exenatide | Placebo |
|---|---|---|
| Gastric Emptying Half-time (T 1/2) of Solids | 187 (141 to 240) | 86 (73 to 125) |
Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.
| percentage of meal emptied | Exenatide | Placebo |
|---|---|---|
| Percentage of Gastric Contents Emptied at 1 Hour | 12.4 (8 to 18.5) | 38.2 (26.6 to 42.1) |
| kg | Exenatide | Placebo |
|---|---|---|
| Change in Body Weight | -0.95 (-2.1 to -0.7) | -0.55 (-2.1 to 0.3) |
In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) 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.
| mL | Exenatide | Placebo |
|---|---|---|
| Satiation Expressed as Volume to Fullness | 705 (510 to 795) | 675 (413 to 825) |
In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) 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 5.
| mL | Exenatide | Placebo |
|---|---|---|
| Maximum Tolerated Volume | 1244 (918 to 1452) | 1052 (859.1 to 1422) |
Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard "all you can eat" meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software.
| kcal | Exenatide | Placebo |
|---|---|---|
| Buffet Meal Intake (kcal) | 977 (713 to 1336) | 1110 (680.3 to 1658) |
Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from "none"(0) to "worst ever" (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating "none" and 400 indicating "worst ever."
| mm | Exenatide | Placebo |
|---|---|---|
| Aggregate Satiation Symptom Score | 145 (133.5 to 204) | 172 (110 to 237) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exenatide | — | 0/10 (0%) | 0/10 (0%) |
| Placebo | — | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Exenatide | Placebo | Total |
|---|---|---|---|
| Median | 34 (33 to 46.8) | 42.5 (25.3 to 49.5) | 39.3 (25.3 to 49.5) |
| Sex: Female, Male(Participants) | Exenatide | Placebo | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 4 | 3 | 7 |
| Region of Enrollment(participants) | Exenatide | Placebo | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
Plan to share: No
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