Obesity
Conditions
Keywords
Sleeve Gastrectomy, Roux-en-Y Gastric Bypass
Brief summary
The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.
Detailed description
Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider that the postprandial rise in GLP-1 might affect feeding behavior after RYGB, and to a lesser extent SG, where the increase in GLP-1 is less marked.
Interventions
DRUGSaline
Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
DRUGExendin-9,39
Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.
Sponsors
The Obesity Society
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years * Healthy, with no active systemic illness
Exclusion criteria
* Pregnancy * Functional or organic bowel symptoms * Systemic illness * Diabetes * Bariatric surgery \> 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caloric Intake | 5 hours | caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Transit Measured Using Scintigraphy | 4 hours | Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cross-over Design Subjects will be studied on 2 occasions, in random order.
During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.
During the Saline study day they will be infused with saline as a control | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | IV lost during 2nd study | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Cross-over Design |
|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Caloric Intake
caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal
Time frame: 5 hours
Population: Analysis was confined to participants who did not withdraw consent after screening
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Saline Then Exendin-9,39 | Caloric Intake | Saline infusion | 531 calories | Standard Error 71 |
| First Saline Then Exendin-9,39 | Caloric Intake | Exendin-9,39 infusion | 444 calories | Standard Error 65 |
| First Exendin-9,39 Then Saline | Caloric Intake | Saline infusion | 465 calories | Standard Error 107 |
| First Exendin-9,39 Then Saline | Caloric Intake | Exendin-9,39 infusion | 494 calories | Standard Error 98 |
Secondary
Gastrointestinal Transit Measured Using Scintigraphy
Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal
Time frame: 4 hours
Population: Analysis was confined to participants who did not withdraw consent after screening
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| First Saline Then Exendin-9,39 | Gastrointestinal Transit Measured Using Scintigraphy | Saline infusion | 63 minutes | Standard Error 13 |
| First Saline Then Exendin-9,39 | Gastrointestinal Transit Measured Using Scintigraphy | Exendin-9,39 infusion | 100 minutes | Standard Error 24 |
| First Exendin-9,39 Then Saline | Gastrointestinal Transit Measured Using Scintigraphy | Saline infusion | 48 minutes | Standard Error 14 |
| First Exendin-9,39 Then Saline | Gastrointestinal Transit Measured Using Scintigraphy | Exendin-9,39 infusion | 141 minutes | Standard Error 43 |