Trial Outcomes & Findings for Vagal Nerve Stimulation and Glucose Metabolism (NCT NCT01117311)

Last Updated: 2014-01-06

Results Overview

Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

baseline, 2 weeks

Results posted on

2014-01-06

Participant Flow

Subjects will be recruited out of the study population for a previous multi-center observational study examining the long-term effects of vagal stimulation. In this previous study the Vagal Nerve Blocker (VNB) was implanted.

9 subjects were screened and enrolled, but 2 subjects did not return after the screening visit.

Participant milestones

Participant milestones
Measure	VNB Off First, Then VNB on Subjects assigned to this reporting group had the vagal nerve blocker (VNB) off first for the first intervention (Mixed Meal 2), then VNB on for the second intervention (Mixed Meal 3).	VNB on First, Then VNB Off Subjects assigned to this reporting group had the vagal nerve blocker (VNB) on first for the first intervention (Mixed Meal 2), then VNB off for the second intervention (Mixed Meal 3).
Lead-in Mixed Meal 1 STARTED	3	4
Lead-in Mixed Meal 1 COMPLETED	3	4
Lead-in Mixed Meal 1 NOT COMPLETED	0	0
First Intervention - Mixed Meal 2 STARTED	3	4
First Intervention - Mixed Meal 2 COMPLETED	3	4
First Intervention - Mixed Meal 2 NOT COMPLETED	0	0
Second Intervention - Mixed Meal 3 STARTED	3	4
Second Intervention - Mixed Meal 3 COMPLETED	3	4
Second Intervention - Mixed Meal 3 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vagal Nerve Stimulation and Glucose Metabolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=7 Participants Includes groups randomized to have the VNB off first and the VNB on first.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	53.1 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 2 weeks

Outcome measures

Outcome measures
Measure	VNB on n=7 Participants The implanted Vagal Nerve Blocker will be on at the time of study.	VNB Off n=7 Participants The implanted Vagal Nerve Blocker will be off at the time of study.
Disposition Index	703 10^-14dl/kg/min^2 per pmol/l Standard Error 240	532 10^-14dl/kg/min^2 per pmol/l Standard Error 145

SECONDARY outcome

Timeframe: approximately 2 hours after radiolabeled meal is ingested

Gastric emptying half time is the time for half of the ingested solids or liquids to leave the stomach.

Outcome measures

Outcome measures
Measure	VNB on n=7 Participants The implanted Vagal Nerve Blocker will be on at the time of study.	VNB Off n=7 Participants The implanted Vagal Nerve Blocker will be off at the time of study.
Gastric Emptying Half-time	167 minutes Standard Error 17	160 minutes Standard Error 23

Adverse Events

VNB Off

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VNB on

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Adrian Vella

Mayo Clinic

Phone: 507-284-3289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place