Gastroparesis NondiabeticNCT07635576
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
A study testing Gastric Electrical Stimulator in people with Gastroparesis Nondiabetic, run by Indiana University at 1 site in United States.
Trial summary
The goal of this study is to determine how much effect turning off an individual's Gastric Electrical Stimulator (GES) for up to four hours will have on levels of insulin, C-peptide, GLP-1 and glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis Nondiabetic
- What is being tested?
- Gastric Electrical Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age.
- Documented diagnosis of gastroparesis
- Not taking diabetic prescribed exogenous insulin.
- Patient has a GES device that has been implanted for at least 3 months.
- Willing to give up to 8 blood samples.
- Willing to lie in a bed for up to 5.5 hours.
Who cannot join
- Pregnancy
- History of allergic reaction to EKG lead placement adhesives.
- Unable to give informed consent.
- Unwilling to give up to 8 5 ml blood samples.
- Unwilling to lie in a bed for up to 5.5 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Maureen V Schilling, BS, 3172782064, maschi@iu.edu
Thomas V Nowak, MD, 317-948-4272, tvnowak@iu.edu
About this study
Official title: Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects
The goal of this study is to determine how much effect turning off an individual's Gastric Electrical Stimulator (GES) for up to four hours will have on levels of insulin, C-peptide, GLP-1 and glucose levels.
Read the detailed description
Up to thirty-two adult patients with gastroparesis who have undergone implantation of a gastric stimulation device at least three months prior may participate in this study, which will be completed at a single study visit.
The study consists of two groups, an EXPERIMENTAL group that undergoes turning off the GES and a CONTROL group that does not undergo the turning off of the GES. The subjects are randomized to either the control or experimental group.
After an overnight fast, consented and eligible patients are placed in the supine position on a hospital bed, and an intravenous line is inserted and capped. EKG electrodes will be placed on the chest, arms/legs, behind each ear and just under the jaw on each side to record cardiac and vagal nerve activity.
The study consists of three separate and consecutive periods:
- Baseline, a 20-minute period during which GES is left ON at each patient's pre-study settings;
- Experimental, a 4-hour period during which the GES device is turned OFF for participants in the experimental group;
- Recovery, a 20-minute period during which GES is turned back ON to the patient's pre-study settings for participants in the experimental group.
A 5-ml sample of blood will be collected from each patient after placement of the flexible IV catheter secured with tape, and after the Baseline, and Recovery study periods. During the Experimental period a blood sample is withdrawn after 30 minutes and then again at the 1-hour, 2-hour, 3-hour and 4-hour intervals through a flexible IV catheter secured with tape, with the possibility of up to 8 blood draws over the duration of the study. EKG and vagal nerve activity will be recorded continuously through the 3 study periods.
- Conditions
- Gastroparesis Nondiabetic
- Being tested
- Gastric Electrical Stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Electrical StimulatorDevice
Also called GES
Device will either be turned off for the duration of the experimental period.
| Study group | Role | What they receive |
|---|---|---|
| The OFF Group | Experimental | This group of subjects will have their GES interrogated and observed as well as having the device turned off for the duration of the experiment. The device will then be re-interrogated and turned back on at the end of the experiment. Receives: Device: Gastric Electrical Stimulator |
| Control Group | No intervention | This group of subjects will undergo the same procedures as the experimental group, except that their GES will not be turned off during the experimental period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum insulin
To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin.
Measured: Day 1
Change in serum C-peptide
To define the effect of prolonged four-hour withdrawal of gastric in human subjects. Insulin and C-peptide are co-primary end points.
Measured: Day 1
Secondary outcomes (2)
Changes in serum glucose
To compare the changes in serum GLP-1 and glucose levels after 4-hour withdrawal of gastric electrical stimulation to a control group that does not undergo withdrawal of gastric electrical stimulation.
Measured: Day 1
Changes in serum GLP-1
To compare the changes in serum GLP-1 and glucose levels after 4-hour withdrawal of gastric electrical stimulation to a control group that does not undergo withdrawal of gastric electrical stimulation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start23 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastroparesis NondiabeticStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin and C-peptide levels in human subjects. Insulin and C-peptide are co-primary end points.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas V. Nowak, Indiana University
- Investigators
- Thomas V Nowak, MD, Principal investigator, IU School of Medicine/IU Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635576
- Sponsor's protocol ID
- 30020
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Payne SC, Ward G, Fallon JB, Hyakumura T, Prins JB, Andrikopoulos S, MacIsaac RJ, Villalobos J. Blood glucose modulation and safety of efferent vagus nerve stimulation in a type 2 diabetic rat model. Physiol Rep. 2022 Apr;10(8):e15257. doi: 10.14814/phy2.15257.
PubMed 35439355Kozorosky EM, Lee CH, Lee JG, Nunez Martinez V, Padayachee LE, Stauss HM. Transcutaneous auricular vagus nerve stimulation augments postprandial inhibition of ghrelin. Physiol Rep. 2022 Apr;10(8):e15253. doi: 10.14814/phy2.15253.
PubMed 35441808Vosseler A, Zhao D, Fritsche L, Lehmann R, Kantartzis K, Small DM, Peter A, Haring HU, Birkenfeld AL, Fritsche A, Wagner R, Preissl H, Kullmann S, Heni M. No modulation of postprandial metabolism by transcutaneous auricular vagus nerve stimulation: a cross-over study in 15 healthy men. Sci Rep. 2020 Nov 24;10(1):20466. doi: 10.1038/s41598-020-77430-2.
PubMed 33235256van der Voort IR, Becker JC, Dietl KH, Konturek JW, Domschke W, Pohle T. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 Jan;113(1):38-42. doi: 10.1055/s-2004-830525.
PubMed 15662594Hampton RF, Jimenez-Gonzalez M, Stanley SA. Unravelling innervation of pancreatic islets. Diabetologia. 2022 Jul;65(7):1069-1084. doi: 10.1007/s00125-022-05691-9. Epub 2022 Mar 29.
PubMed 35348820
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Effect of Gastric Electrical Stimulation on Serum Insulin Levels in Human Subjects
- ClinicalTrials.gov ID
- NCT07635576
- Acronym / sponsor ID
- 30020
- Conditions
- Gastroparesis Nondiabetic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine how much effect turning off an individual's Gastric Electrical Stimulator (GES) for up to four hours will have on levels of insulin, C-peptide, GLP-1 and glucose levels.
Detailed description
Up to thirty-two adult patients with gastroparesis who have undergone implantation of a gastric stimulation device at least three months prior may participate in this study, which will be completed at a single study visit.
The study consists of two groups, an EXPERIMENTAL group that undergoes turning off the GES and a CONTROL group that does not undergo the turning off of the GES. The subjects are randomized to either the control or experimental group.
After an overnight fast, consented and eligible patients are placed in the supine position on a hospital bed, and an intravenous line is inserted and capped. EKG electrodes will be placed on the chest, arms/legs, behind each ear and just under the jaw on each side to record cardiac and vagal nerve activity.
The study consists of three separate and consecutive periods:
- Baseline, a 20-minute period during which GES is left ON at each patient's pre-study settings;
- Experimental, a 4-hour period during which the GES device is turned OFF for participants in the experimental group;
- Recovery, a 20-minute period during which GES is turned back ON to the patient's pre-study settings for participants in the experimental group.
A 5-ml sample of blood will be collected from each patient after placement of the flexible IV catheter secured with tape, and after the Baseline, and Recovery study periods. During the Experimental period a blood sample is withdrawn after 30 minutes and then again at the 1-hour, 2-hour, 3-hour and 4-hour intervals through a flexible IV catheter secured with tape, with the possibility of up to 8 blood draws over the duration of the study. EKG and vagal nerve activity will be recorded continuously through the 3 study periods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin and C-peptide levels in human subjects. Insulin and C-peptide are co-primary end points.
| Arm | Type | Receives |
|---|---|---|
| The OFF Group | Experimental | Device: Gastric Electrical StimulatorThis group of subjects will have their GES interrogated and observed as well as having the device turned off for the duration of the experiment. The device will then be re-interrogated and turned back on at the end of the experiment. |
| Control Group | No intervention | –This group of subjects will undergo the same procedures as the experimental group, except that their GES will not be turned off during the experimental period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age.
- Documented diagnosis of gastroparesis
- Not taking diabetic prescribed exogenous insulin.
- Patient has a GES device that has been implanted for at least 3 months.
- Willing to give up to 8 blood samples.
Key exclusion criteria (5 listed)
- Pregnancy
- History of allergic reaction to EKG lead placement adhesives.
- Unable to give informed consent.
- Unwilling to give up to 8 5 ml blood samples.
- Unwilling to lie in a bed for up to 5.5 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Electrical StimulatorAlso: GESDevice will either be turned off for the duration of the experimental period. | Device | The OFF Group |
Primary outcome
Change in serum insulin
Time frame: Day 1
To define the effect of prolonged four-hour withdrawal of gastric electrical stimulation on serum insulin.
Change in serum C-peptide
Time frame: Day 1
To define the effect of prolonged four-hour withdrawal of gastric in human subjects. Insulin and C-peptide are co-primary end points.
2 secondary outcomes
Changes in serum glucose
Time frame: Day 1
Changes in serum GLP-1
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 35439355Payne SC, Ward G, Fallon JB, Hyakumura T, Prins JB, Andrikopoulos S, MacIsaac RJ, Villalobos J. Blood glucose modulation and safety of efferent vagus nerve stimulation in a type 2 diabetic rat model. Physiol Rep. 2022 Apr;10(8):e15257. doi: 10.14814/phy2.15257.
- Background: PubMed 35441808Kozorosky EM, Lee CH, Lee JG, Nunez Martinez V, Padayachee LE, Stauss HM. Transcutaneous auricular vagus nerve stimulation augments postprandial inhibition of ghrelin. Physiol Rep. 2022 Apr;10(8):e15253. doi: 10.14814/phy2.15253.
- Background: PubMed 33235256Vosseler A, Zhao D, Fritsche L, Lehmann R, Kantartzis K, Small DM, Peter A, Haring HU, Birkenfeld AL, Fritsche A, Wagner R, Preissl H, Kullmann S, Heni M. No modulation of postprandial metabolism by transcutaneous auricular vagus nerve stimulation: a cross-over study in 15 healthy men. Sci Rep. 2020 Nov 24;10(1):20466. doi: 10.1038/s41598-020-77430-2.
- Background: PubMed 15662594van der Voort IR, Becker JC, Dietl KH, Konturek JW, Domschke W, Pohle T. Gastric electrical stimulation results in improved metabolic control in diabetic patients suffering from gastroparesis. Exp Clin Endocrinol Diabetes. 2005 Jan;113(1):38-42. doi: 10.1055/s-2004-830525.
- Results publication: PubMed 35348820Hampton RF, Jimenez-Gonzalez M, Stanley SA. Unravelling innervation of pancreatic islets. Diabetologia. 2022 Jul;65(7):1069-1084. doi: 10.1007/s00125-022-05691-9. Epub 2022 Mar 29.
- Block Randomization in Clinical Trials: Video Tutorial in Microsoft ExcelLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas V Nowak, MD principal investigator
IU School of Medicine/IU Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric Electrical Stimulator in people with Gastroparesis Nondiabetic, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen V Schilling, BS (3172782064, maschi@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum insulin (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07635576, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.