Exendin-9,39 and Satiety After Bariatric Surgery

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02779075
• Collaborator: The Obesity Society (Other)
• Enrollment: 29
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Saline; Drug: Exendin-9,39	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Exendin-9,39 and Satiety After Bariatric Surgery
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline 0.9% NaCL (saline) intravenously for 6 hours.	Drug: Saline; Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
Active Comparator: Exendin-9,39 Exendin-9,39 intravenously for 6 hours.	Drug: Exendin-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.

Outcome Measures

Primary Outcome Measures

1. Caloric Intake [5 hours]

   caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• The Obesity Society

Investigators

• Principal Investigator: Adrian Vella, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 31, 2016

More Information

Publications

None provided.

• Responsible Party: Adrian Vella, MD, FRCP (Edin), Consultant Division or Endocrinolgy, Diabetes and Nutrition, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02779075
• Other Study ID Numbers: 16-001973
• First Posted: May 20, 2016
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Adrian Vella, MD, FRCP (Edin), Consultant Division or Endocrinolgy, Diabetes and Nutrition, Mayo Clinic: Sleeve Gastrectomy; Roux-en-Y Gastric Bypass

Study Results

Participant Flow

Arm/Group Title	First Saline Then Exendin-9,39	First Exendin-9,39 Then Saline
Arm/Group Description	First Intervention (Day 1 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed.	First Intervention (Day 1 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed.
Period Title: Overall Study
STARTED	16	13
COMPLETED	14	10
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Cross-over Design
Arm/Group Description	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
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.4 (11.2)
Sex: Female, Male (Count of Participants)
Female	27 93.1%
Male	2 6.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	28 96.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Caloric Intake
Description	caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal
Time Frame	5 hours

Outcome Measure Data

Analysis Population Description

Analysis was confined to participants who did not withdraw consent after screening

Arm/Group Title	First Saline Then Exendin-9,39	First Exendin-9,39 Then Saline
Arm/Group Description	First Intervention (Day 1 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed.	First Intervention (Day 1 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed.
Measure Participants	16	13
Saline infusion	531 (71)	465 (107)
Exendin-9,39 infusion	444 (65)	494 (98)

2. Secondary Outcome

Title	Gastrointestinal Transit Measured Using Scintigraphy
Description	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

Outcome Measure Data

Analysis Population Description

Analysis was confined to participants who did not withdraw consent after screening

Arm/Group Title	First Saline Then Exendin-9,39	First Exendin-9,39 Then Saline
Arm/Group Description	First Intervention (Day 1 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed.	First Intervention (Day 1 (6 hours of Exendin-9,39 infusion) during which a test meal and a free-choice buffet meal were consumed, Washout (14 days), and the Second Intervention Day 16 (6 hours of saline infusion) during which a test meal and a free-choice buffet meal were consumed.
Measure Participants	16	13
Saline infusion	63 (13)	48 (14)
Exendin-9,39 infusion	100 (24)	141 (43)

Adverse Events

Time Frame	duration of experiment i.e 6 hours
Arm/Group Title	Saline		Exendin-9,39
Arm/Group Description	0.9% NaCL (saline) intravenously for 6 hours. Saline: Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.		Exendin-9,39 intravenously for 6 hours. Exendin-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.
All Cause Mortality
	Saline		Exendin-9,39
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Saline		Exendin-9,39
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Saline		Exendin-9,39
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/24 (4.2%)
Skin and subcutaneous tissue disorders
infiltration of intravenous line	0/24 (0%)		1/24 (4.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.