Primary outcomeMedian· time frame is 30 days after the initiation of dose.
Gastric Emptying Half-time (T 1/2) of Solids
| Group | Value (minutes) |
|---|---|
| Exenatide | 187 |
| Placebo | 86 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataEffect of Exenatide in Obese Patients With Accelerated Gastric Emptying
NCTNCT02160990 (opens ClinicalTrials.gov in a new tab)Other id14-002683 ExenatideOther idR01DK067071Other idUL1TR000135
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 20 participants (actual)
- Sponsor
- Mayo Clinic · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Jun 2014
- Primary completion
- Mar 2015
- Completion
- Mar 2015
- First posted
- 11 Jun 2014 (estimated)
- Last update posted
- 9 Aug 2016 (estimated)
- Conditions
- Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016
- Ph 4
Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying
NCT02160990Jun 2014 to Mar 2015
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ExenatideDrug
- PlaceboDrug
Arms2
Experimental
Exenatide
Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
Placebo comparator
Placebo
Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Primary outcomes1
Outcomes the sponsor listed as primary.
Gastric Emptying Half-time (T 1/2) of Solids
Time frame · time frame is 30 days after the initiation of dose.
Registry description
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).
Secondary outcomes(6)
Percentage of Gastric Contents Emptied at 1 Hour
Time frame · Visit 4, approximately 1 hours after radiolabeled meal was ingested
Registry description
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.
Change in Body Weight
Time frame · baseline, day 30
Satiation Expressed as Volume to Fullness
Time frame · Visit 3, approximately 30 minutes after liquid meal
Registry description
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.
Maximum Tolerated Volume
Time frame · Visit 3, approximately 30 minutes after liquid meal
Registry description
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.
Buffet Meal Intake (kcal)
Time frame · Visit 4, approximately 30 minutes after start of "all you can eat" meal
Registry description
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.
Aggregate Satiation Symptom Score
Time frame · Visit 3, approximately 30 min after ingestion of nutrient drink test
Registry description
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."
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMedian· Visit 4, approximately 1 hours after radiolabeled meal was ingested
Percentage of Gastric Contents Emptied at 1 Hour
| Group | Value (percentage of meal emptied) |
|---|---|
| Exenatide | 12.4 |
| Placebo | 38.2 |
Secondary outcomeMedian· baseline, day 30
Change in Body Weight
| Group | Value (kg) |
|---|---|
| Exenatide | -0.95 |
| Placebo | -0.55 |
Secondary outcomeMedian· Visit 3, approximately 30 minutes after liquid meal
Satiation Expressed as Volume to Fullness
| Group | Value (mL) |
|---|---|
| Exenatide | 705 |
| Placebo | 675 |
Secondary outcomeMedian· Visit 3, approximately 30 minutes after liquid meal
Maximum Tolerated Volume
| Group | Value (mL) |
|---|---|
| Exenatide | 1244 |
| Placebo | 1052 |
Secondary outcomeMedian· Visit 4, approximately 30 minutes after start of "all you can eat" meal
Buffet Meal Intake (kcal)
| Group | Value (kcal) |
|---|---|
| Exenatide | 977 |
| Placebo | 1110 |
Secondary outcomeMedian· Visit 3, approximately 30 min after ingestion of nutrient drink test
Aggregate Satiation Symptom Score
| Group | Value (mm) |
|---|---|
| Exenatide | 145 |
| Placebo | 172 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatideParticipants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days. | – | 0 / 10 | 0 / 10 |
| PlaceboParticipants randomized to this arm received placebo subcutaneously twice daily for 30 days. | – | 0 / 10 | 0 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
PubMed tag: none · 2015
7 results
Exenatide in obesity with accelerated gastric emptying: a randomized, pharmacodynamics study.
Acosta et al. 2015Physiological reportscited by 65
PMID 26542264PMC4632965DOI 10.14814/phy2.12610PUB-26542264
CC BY7 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Obese subjects with BMI\> 30 Kg/m\^2: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
* Women of childbearing potential will have negative pregnancy test before initiation of medication.
* Gastric emptying (GE): Accelerated GE T1/2 \< 79 minutes or GE 1h\>35 %
Exclusion Criteria:
* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
* Unstable heart disease as evidenced by ongoing angina
* Congestive heart failure
* Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)
* Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)
* Use of anti-diabetic drugs including metformin,
* History of nephrolithiasis,
* Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire (PHQ-9) total score ≥10).
* Gastroparesis
* Inflammatory bowel disease or irritable bowel syndrome
* Malignancy treated with chemotherapy within the past 3 years
* History of pancreatitis
* Renal insufficiency (eGFR less than 50 ml/min)
* Concomitant use of monoamine oxidase inhibitors (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants
* Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale (HADS) self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
* Intake of medication that could interfere with the interpretation of the study or cause drug interaction (i.e., ketoconazole, erythromycin). Specifically, birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible.
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