Trial Outcomes & Findings for Exendin-9,39 and Satiety After Bariatric Surgery (NCT NCT02779075)

NCT ID: NCT02779075

Last Updated: 2020-05-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 5 hours
• Results posted on: 2020-05-01

Participant Flow

Participant milestones

Measure	First Saline Then Exendin-9,39 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 Exendin-9,39 Then Saline 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.
Overall Study STARTED	16	13
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	First Saline Then Exendin-9,39 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 Exendin-9,39 Then Saline 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.
Overall Study Withdrawal by Subject	1	3
Overall Study IV lost during 2nd study	1	0

Baseline Characteristics

Exendin-9,39 and Satiety After Bariatric Surgery

Baseline characteristics by cohort

Measure	Cross-over Design n=29 Participants 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
Age, Continuous	45.4 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 hours

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

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

Outcome measures

Measure	First Saline Then Exendin-9,39 n=16 Participants 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 Exendin-9,39 Then Saline n=13 Participants 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.
Caloric Intake Saline infusion	531 calories Standard Error 71	465 calories Standard Error 107
Caloric Intake Exendin-9,39 infusion	444 calories Standard Error 65	494 calories Standard Error 98

SECONDARY outcome

Timeframe: 4 hours

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

Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal

Outcome measures

Measure	First Saline Then Exendin-9,39 n=16 Participants 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 Exendin-9,39 Then Saline n=13 Participants 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.
Gastrointestinal Transit Measured Using Scintigraphy Saline infusion	63 minutes Standard Error 13	48 minutes Standard Error 14
Gastrointestinal Transit Measured Using Scintigraphy Exendin-9,39 infusion	100 minutes Standard Error 24	141 minutes Standard Error 43

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exendin-9,39

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Saline n=24 participants at risk 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 n=24 participants at risk 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.
Skin and subcutaneous tissue disorders infiltration of intravenous line	0.00% 0/24 • duration of experiment i.e 6 hours	4.2% 1/24 • duration of experiment i.e 6 hours

Additional Information

Adrian Vella

Mayo Clinic

Phone: 507-202-8490

Email: vella.adrian@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place