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Vagal Nerve Stimulation and Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT01117311
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Type 2 Diabetes
Obesity
Gastric Emptying
Interventions Device: VNB on
Device: VNB off
Enrollment 9
Recruitment Details 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.
Pre-assignment Details 9 subjects were screened and enrolled, but 2 subjects did not return after the screening visit.
Arm/Group Title VNB Off First, Then VNB on VNB on First, Then VNB Off
Hide Arm/Group Description 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). 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).
Period Title: Lead-in Mixed Meal 1
Started 3 4
Completed 3 4
Not Completed 0 0
Period Title: First Intervention - Mixed Meal 2
Started 3 4
Completed 3 4
Not Completed 0 0
Period Title: Second Intervention - Mixed Meal 3
Started 3 4
Completed 3 4
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to have the VNB off first and the VNB on first.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
53.1  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Disposition Index
Hide Description 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.
Time Frame baseline, 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNB on VNB Off
Hide Arm/Group Description:
The implanted Vagal Nerve Blocker will be on at the time of study.
The implanted Vagal Nerve Blocker will be off at the time of study.
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: 10^-14dl/kg/min^2 per pmol/l
703  (240) 532  (145)
2.Secondary Outcome
Title Gastric Emptying Half-time
Hide Description Gastric emptying half time is the time for half of the ingested solids or liquids to leave the stomach.
Time Frame approximately 2 hours after radiolabeled meal is ingested
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VNB on VNB Off
Hide Arm/Group Description:
The implanted Vagal Nerve Blocker will be on at the time of study.
The implanted Vagal Nerve Blocker will be off at the time of study.
Overall Number of Participants Analyzed 7 7
Mean (Standard Error)
Unit of Measure: minutes
167  (17) 160  (23)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VNB Off VNB on
Hide Arm/Group Description The implanted Vagal Nerve Blocker will be off at the time of study. The implanted Vagal Nerve Blocker will be on at the time of study.
All-Cause Mortality
VNB Off VNB on
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VNB Off VNB on
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VNB Off VNB on
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
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.
Results Point of Contact
Name/Title: Dr. Adrian Vella
Organization: Mayo Clinic
Phone: 507-284-3289
Responsible Party: Adrian Vella, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01117311     History of Changes
Other Study ID Numbers: 09-008825
R01DK082396 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: May 4, 2010
First Posted: May 5, 2010
Results First Submitted: August 21, 2013
Results First Posted: January 6, 2014
Last Update Posted: January 6, 2014